Comparison of Intraoperative Fluid by Goal-Directed and Conventional Fluid Administration in Patients Undergoing Early Decompressive Craniectomy: A Prospective Randomized Controlled Trial

Abstract

Background

Optimal fluid administration is important following traumatic brain injury (TBI) due to its associated fluid imbalance and cardiovascular abnormalities. Liberal use of fluids may be associated with overload and adverse cardiovascular effects. Hence, the study was conducted to compare the effect of goal-directed fluid therapy (GDT) with conventional fluid therapy (CFT) in moderate to severe TBI patient scheduled for early decompressive craniectomy.

Materials and Methods

Sixty-four patients with moderate to severe TBI were randomly allocated into Group A (goal-directed therapy [GDT]) in which intraoperative fluid administration was guided by dynamic parameters using FloTrac and Group B (conventional fluid therapy [CFT]) in which fluid was administered to target a mean arterial pressure of 70 mm Hg. The primary objective was to compare the intraoperative fluid volume administered. Comparison of blood loss, urine output, ventilator days, ICU days, and hospital days, were secondary outcomes.

Results

There was no statistical difference in intraoperative fluid volume between groups (2,567 vs. 2,670 mL; p = 0.51) with lesser episodes of hypotension in Group A (38 vs. 45). Group A had a significant drop in lactate (0.95 vs. 0.17; p = 0.00) and difference in hematocrit value was significantly lower in group A (9.52 vs. 12.04; p 0.04). There was no significant difference in blood loss (p = 0.77), urine output (p = 0.22), ventilator days (p = 0.20), ICU days (p = 0.23), and length of hospital stay (p = 0.39).

Conclusion

GDT had no difference in intraoperative fluid volume but fewer hypotension episodes, more drop of lactate, and lesser fall in hematocrit as compared with CFT in moderate to severe TBI patients undergoing early decompressive craniectomy.

Keywords

brain injury - decompressive craniectomy - fluid therapy - hematocrit - traumatic

Introduction

Traumatic brain injury (TBI) is an acquired insult to the brain resulting in impairment of physical, cognitive, and/or psychological functions.[1] It is a significant cause of mortality and disability worldwide.[1] [2] To reduce mortality, the Brain Trauma Foundation recommends a three-tiered approach to management, including medical management and surgical decompressive craniectomy (DC) for intractable intracranial hypertension.[3]

TBI is associated with extracranial complications such as neurogenic pulmonary edema, a systemic inflammatory response associated with acute respiratory distress syndrome; myocardial dysfunction, dysthymia, subendocardial ischemia, and hemodynamic instability, and acute kidney injury have been reported in the literature.[4] The goals of fluid therapy in TBI are to preserve cerebral perfusion, control brain volume, and ensure appropriate substrate delivery as the brain is uniquely sensitive to changes in osmolarity and systemic blood pressure.[5] [6] The above considerations, along with the disruption of the blood–brain barrier, warrant a unique approach to fluid management. These objectives also apply during DC as fluid shift and dysregulation are prevalent during surgery under anesthesia, which may affect the patient outcomes.

Previous studies and guidelines have described fluid management in TBI, but there needs to be more literature on fluid management during the perioperative period in TBI patients undergoing surgical management.[7] [8] Conventional management depends on clinical judgment, surgical blood loss estimates, and third space losses. Liberal fluid administered may result in coagulation dysfunction and positive fluid balance, resulting in poor outcomes.[9] [10] [11] Goal-directed fluid therapy (GDT) is the administration of fluids, inotropes, and vasopressors based on precisely measured goals that maintain cardiac output and tissue oxygen delivery based on dynamic parameters. Though GDT is known to be beneficial in reducing intraoperative complications, its role in patients undergoing DC following TBI is still not well established.[12] [13] [14] Hence, this study was conducted to compare intraoperative goal-directed therapy with conventional fluid therapy (CFT) in patients with isolated TBI undergoing early DC. We hypothesized that intraoperative GDT would improve clinical parameters and patient outcomes. The primary objective was to compare the intraoperative fluid volume administered. Secondary objectives included intraoperative blood loss and urine output, blood lactate levels, hematocrit, use of vasoactive drugs, postoperative duration of mechanical ventilation, length of ICU and hospital stay, and FOUR (Full Outline of UnResponsiveness) score.

Materials and Methods

Study Design

The prospective randomized controlled trial was conducted in the operation theater (OT) of a Level 1 Trauma center of a tertiary-care hospital in North India from March 2021 to April 2023. The study was approved by the institutional ethics committee (INT/IEC/2021/SPL-126, dated 22^nd January 2021) and registered with the Clinical Trial Registry of India (CTRI/2021/02/031242; dated 12^th February 2021) before enrolment of the first patient. Written informed consent was obtained from all patients' next of kin. This article adheres to the applicable guidelines of Consolidated Standards of Reporting Trials (CONSORT).

Preoperative Protocol

Patients received in our trauma bay were managed as per our hospital triage protocol, which includes guidelines postulated by ATLS, where they underwent a primary survey and secondary survey followed by definitive treatment of the head injury.

All patients received fluid bolus of isotonic fluid for resuscitation in the trauma emergency as per ATLS protocol with a systolic blood pressure target >110 mm Hg or higher in patients between 15 and 49 years and >100 mm Hg or higher for patients between 50 and 69 years of age. The other targets of preoperative resuscitation included maintaining HB >7 g/dL, INR <1.4 and platelets >75,000/dL, and glucose 80 to 180 mg/dL.[15]

Patient Selection

Intubated patients aged 18 to 65 years, with isolated moderate to severe TBI undergoing DC within 24 hours of trauma, were included in the study. Patient with known coronary artery disease, congestive heart failure, known valvular disease, atrial fibrillation or flutter, acute renal dysfunction, documented history of portal hypertension, pulmonary insufficiency, pregnancy, extreme body mass index (BMI) >45 or <17, blunt trauma abdomen and chest and requiring tidal volumes <8 mL/kg were excluded.

Randomization, Allocation Concealment, and Blinding

Patients were randomized using computer-generated random number tables and allocated by sequentially labeled opaque envelope to one of the study groups in an allocation ratio of 1:1. The envelope was opened after shifting the patients inside the OT. The person who assessed the outcome parameters was unaware of the study group to ensure the blinding.

Conduct of Anesthesia

Standard ASA monitors (pulse oximetry, electrocardiography, non-invasive blood pressure) were attached to the patient after arrival into OT and connected to the monitor of the Datex-Ohmeda Avance S2 (GE Healthcare, Helsinki, Finland) machine. The patients were mechanically ventilated with a tidal volume of 8 to 10 mL/kg, and respiratory rates were adjusted to achieve an EtCO₂ of 30 to 35 mm Hg (PaCO₂ of 35–40 mm Hg). Arterial pressure monitoring done using radial artery cannulation with the transducer kept at the level of patient's external auditory meatus. The patients received total intravenous anesthesia with intravenous fentanyl and propofol infusion. Bolus doses of intravenous atracurium were used for muscle relaxation during surgery, targeting a train-of-four count of less than 2. During the intraoperative period, we measured the patient's hourly lactate and hematocrit levels via arterial blood gas analysis. Crystalloids were used for intraoperative fluid management as per the assigned study group . Patients received mannitol at a dose of 1 g/kg during the perioperative period for suspected raised intracranial hypertension. All patients were shifted to the trauma intensive care unit for further management.

Group A (GDT protocol): The arterial cannula was connected to the Flo Trac EV-1000 device (Edwards Lifesciences, Irvine, California, United States) using a Flo Trac transducer. Once the complete arterial waveform was traced for 30 seconds and the systolic, diastolic, and mean arterial pressure (MAP) were displayed, the treatment protocol was started. In this group, the protocol described by Mizunoya et al was followed ([Fig. 1]).[16] Three hemodynamic components: stroke volume variation (SVV) <12%, cardiac index (CI) >2.5 L/min/m², and MAP >70 mm Hg were targeted before the dural opening and a MAP of 60 to 70 mm Hg was targeted after dural opening for fluid management. The maintenance fluid rate was manually controlled to achieve these hemodynamic targets, and no specific bolus/maintenance fluid rate was used.

Fig. 1 Protocol of hemodynamic management described by Mizunoya et al,[16] which was followed in group A.

Group B (CFT protocol): Fluid management was started once a complete arterial waveform was displayed. Crystalloid was infused by continuous infusion, targeting a MAP >70 mm Hg before dural opening and a MAP pf 60 to 70 mm Hg after dural opening.

In both the groups, blood and blood products were replaced according to the calculated blood loss (suction + sponges + gauze + drapes) and hematocrit levels from arterial blood gas analysis. The amount and type of fluid given (in total and per body weight), bolus amount of fluid received, blood loss, urine volume, hourly lactate, and hematocrit levels were also recorded. Episodes of hypotension (both cumulative and per patient) were also recorded. Hypotension was defined as MAP < 70 mm Hg on invasive blood pressure monitoring. Hypotension was first addressed with bolus fluid (10 mL/kg) to achieve target MAP >70 mm Hg. If target MAP was not achieved with a complete infusion of the calculated bolus dose, then vasopressor (phenylephrine) infusion started. The number of patients receiving vasoactive drugs was also recorded.

FOUR (Full Outline of UnResponsiveness) score while patient was on ventilator, days of mechanical ventilation, length of ICU, and hospital stay were recorded. The verbal score of GCS was modified for patients who were tracheostomized as per following formula: Derived Verbal Score = −0.3756 + Motor Score × (0.5713) + Eye Score × (0.4233).[17]

Statistical Analysis

Sample population data collected is described as mean ± SD, median (interquartile range), frequencies (number of cases), and percentages. Data were tested for normal distribution by Kolmogorov–Smirnov test. Quantitative variables between the study groups were compared using Student's t-test if normally distributed. Non-normally distributed quantitative and ordinal data were calculated using Mann-Whitney U test. A Chi-square test was used for calculating categorical data. All statistical tests were two-sided and performed at a significance level of α = 0.05. All analysis was performed using IBM SPSS version 25 software.

Sample Size Calculation

Based on a prior study by Wu et al on total infused fluid volume using GDT in supratentorial neoplasm surgery, and assuming a 30% change in total fluid volume administered between the two therapies in our study, a sample size of 28 patients in each group was calculated, with an α error of 0.05 and a power of 90%. Considering attrition/dropout during the study, a sample size of 32 in each group was chosen.[18]

Results

A total of 94 patients were screened for eligibility, out of which 64 patients were enrolled in the study as per inclusion criteria and randomized into Group A (GDT protocol) and Group B (CFT protocol; [Fig. 2]). The age, gender, admission GCS, CT scan findings, surgical procedure, initial fluid given, mannitol given during the intraoperative period, and duration of surgery were comparable between both groups ([Table 1]).

Fig. 2 Consort diagram showing recruitment and allotment details of patient.

Table 1 Patient characteristics, CT head findings, and surgical parameters

Particulars	Overall	Group A (GDT) (n = 32) Mean ± SD	Group B (CFT) (n = 32) Mean ± SD	Abs diff (96 CI)	p-Value
Age[a]	40.08 ± 13.93	36.56 ± 13.57	43.59 ± 13.59	−7.03(−13.81 to −0.24)	0.04
Gender[b] Male/Female	52/10	26/6	28/4		0.49
Weight[a](kg)	66.12 ± 7.28	65.37 ± 7.32	66.87 ± 7.28	−1.50(−5.15 to 2.15)	0.41
Height[a](cm)	169.65 ± 5.54	170.40 ± 5.09	168.90 ± 5.95	1.5(−1.26 to 4.26)	0.28
BMI[a]	22.98 ± 2.21	22.54 ± 2.23	23.42 ± 2.13	−0.88(−1.96 to 0.20)	0.11
Baseline Hematocrit[a]	35.38 ± 5.41	36.13 ± 5.24	34.63 ± 5.56	1.5(−1.19 to 4.19)	0.27
Baseline lactate[a](mmol/L)	1.96 ± 1.46	2.08 ± 1.54	1.79 ± 1.39	0.29(−0.44 to 1.02)	0.43
GCS at admission[a]	8.16 ± 1.87	8.34 ± 1.84	8.11 ± 1.92	0.23(−0.70 to 1.16)	0.62
Baseline crystalloids received	1,391.47 ± 196.23	1,408.63 ± 212.54	1,307.23 ± 201.36	101.40 (−423.85 to 746.65)	0.58
CT scan[d]
SDH	6	3	3		0.63[c]
Contusion + MLS	19	10	9
SDH + EDH + Contusion	4	2	2
SDH + Contusion + MLS	12	4	8
EDH + Contusion + MLS	4	2	2
EDH + Contusion + Skull fracture	13	7	6
Contusion + Skull fracture	6	4	2
Surgery done
Rt FTP DHC	28	14	14		0.99[c]
Lt FTP DHC	18	9	9
Bifrontal craniectomy	6	3	3
Lt FTP DHC and EDH evacuation	12	6	6
Duration of surgery (hours)[a]	3.39 ± 0.39	3.43 ± 0.45	3.38 ± 0.37	0.05(−0.15 to 0.25)	0.62

Abbreviations: BMI, body mass index; DHC, decompressive hemicraniectomy; EDH, epidural hemorrhage; FTP, frontotemporo-parietal; GCS, Glasgow coma scale; MLS, midline shift >0.5; SDH, subdural hemorrhage.

^a Student t-test.

^b Chi square.

^c Mann-Whitney test.

^d A single patient may have more than one CT scan finding.

The mean intraoperative fluid volume in group A was lesser compared with group B [2,567.81 mL (39.28 mL/kg) versus 2,670.62 mL (39.93 mL/kg), absolute difference: –102.8 mL] but the difference was not statistically significant (p − 0.51). Both the groups were comparable concerning the amount of bolus fluid administered, episodes of hypotension, mean surgical blood loss and urine volume. Compared with the baseline values, there was a significant decrease in mean hematocrit levels postoperatively in both groups (p = 0.00; [Fig. 3]). However, the two groups had no statistically significant difference in postoperative hematocrit levels (p − 0.20). There was a statistically significant fall in mean lactate level from the baseline value in group A (p = 0.01). The drop in lactate was statistically significant between both groups (p = 0.00; [Fig. 4]). There was no statistically significant difference in serum osmolality. Nineteen patients (29.68%) received mephentermine [7 (21.87%) in group A vs. 12 (37.5%) in group B]. Seven patients (21.87%) in group A and four patients (12.5%) in group B received vasopressor (phenylephrine) infusion ([Table 2]).

Fig. 3 Comparison of hematocrit between two groups.

Fig. 4 Comparison of lactate between two groups.

Table 2 Intraoperative fluid volume, surgical blood loss, urine volume, hematocrit, and lactate values

Parameter	Overall n = 64 mean ± SD (n)	Group A (GDT) n = 32 mean ± SD (n)	Group B (CFT) n = 32 mean ± SD (n)	Abs diff (95 CI)	p-Value[a]
Total intraoperative fluid input (mL)	2,619.21 ± 619.36	2,567.81 ± 534.67	2,670.62 ± 698.75	−102.81(−413.72 to 208.10)	0.51
Fluid per body weight (mL/kg)	39.36 ± 1.31	39.28 ± 1.08	39.93 ± 1.96	−0.65(−1.44 to 0.14)	0.10
Bolus of fluid (mL)	391.47 ± 196.23	468.63 ± 212.54	307.23 ± 201.36	161.40 (−423.85 to 746.65)	0.58
Type of fluid/blood products (mL)
NS	2,236.12 ± 599.21	2,154.83 ± 538.88	2,346.45 ± 564.91	−191.61(−472.09 to 88.87)	0.17
Mannitol	485.71 ± 267.26 (13)	350.00 ± 212.13 (5)	540.00 ± 288.09 (8)	−190(−780.56 to 400.56)	0.44
Plasmalyte	1,050 ± 667.65 (15)	1,285.71 ± 862.99 (8)	814.28 ± 302.37 (7)	471.42(−281.62 to 1,224.47)	0.19
PRBC	365.20 ± 124.53 (25)	359.23 ± 121.13 (13)	371.66 ± 133.20(12)	−12.43(−117.64 to 92.77)	0.80
Platelets	160 (1)	160 (1)	0
FFP	770 ± 14.14 (2)	770 ± 14.14 (2)	0
Cryoprecipitate	0	0	0
Cumulative episodes of hypotension	83	38	45
Average episodes of hypotension per patient	1.33	1.18	1.4
Total intraoperative blood loss[a](mL)	504.68 ± 217.25	496.87 ± 221.04	512.50 ± 216.64	−15.63(−124.99 to 93.73)	0.77
Total intraoperative urine output[a](mL)	512.57 ± 304.57	558.59 ± 353.13	466.56 ± 243.83	92.3(−59.61 to 243.67)	0.22
Haematocrit[a]
Before incision	35.38 ± 5.41	36.13 ± 5.24	34.63 ± 5.56	1.5(−1.19 to 4.19)	0.27
End of surgery	25.94 ± 4.91	27.07 ± 4.76	24.14 ± 4.68	2.93(0.57–5.28)	0.01
ΔHematocrit	10.568 ± 4.96	9.52 ± 5.20	12.04 ± 4.76	–2.52(–5.01 to –0.02)	0.04
p-Value	0.00	0.00	0.00
Lactate[a](mmol/L)
Before incision	1.96 ± 1.46	2.08 ± 1.54	1.89 ± 1.39	0.19(–0.54 to 0.92)	0.60
End of surgery	1.41 ± 1.12	1.15 ± 1.07	1.71 ± 1.02	–0.56(–1.08 to –0.03)	0.03
ΔLactate	0.21 ± 0.62	0.95 ± 0.49	0.17 ± 0.35	0.78(0.56–0.99)	0.00
p-Value	0.01	0.00	0.55
Serum osmolarity (mOsm/kg)	282.21 ± 2.25	285.05 ± 2.82	283.73 ± 1.98	1.32(0.10–2.53)	0.11
Inotropes/Vassopressors (n)
Mephentermine	19	07	12		0.68[b]
Phenylephrine	15	15	0
Noradrenaline	6	0	6
Adrenaline	0	0	0
Vasopressin	0	0	0
Dobutamine	0	0	0
Mannitol received (n)	58	29	29		0.92

Abbreviations: FFP, fresh frozen plasma; PRBC, packed red blood cells.

^a Student t-test.

^b Mann Whitney U test.

Note: n, no of patients; p <0.05 is significant.

Glasgow outcome scale at 3 months was comparable in both the groups. Total ventilator days, FOUR score, ICU days, hospital days, were comparable between the groups ([Table 3]).

Table 3 Total ventilator days, average FOUR score, ICU days, hospital days

Parameter	Group A (GDT) (n = 32)	Group B (CFT) (n = 32)	Abs diff (95 CI)	p-Value
Total ventilator days mean ± SD	3.03 ± 4.46	4.50 ± 4.75	−1.47(−3.77 to 0.83)	0.20[a]
Average FOUR score mean ± SD	9.88 ± 2.41 (n = 30)	8.90 ± 2.87 (n = 29)	0.98(−0.39 to 2.35)	0.16[a]
Total ICU days mean ± SD	11.75 ± 4.71	13.37 ± 6.07	−1.62(−4.33 to 1.09)	0.23[a]
Total hospital days mean ± SD	16.09 ± 6.11	17.46 ± 6.79	−1.37(−4.59 to 1.85)	0.39[a]

Abbreviations: FOUR, Full Outline of UnResponsiveness; SD, standard deviation.

^a Students' t-test.

Note: n, no of patients; p <0.05 is significant.

Discussion

The annual incidence of TBI is around 1.6 million, and 200,000 succumb to it, with young males being the most commonly affected population.[19] TBI causes microvascular injury, which leads to a pathological passage of fluid across the blood–brain barrier, leading to cerebral edema.[6] In patients with TBI, cerebral causes irreversible tissue damage, leading to poor outcomes. A formulaic approach has been supplanted by GDT to monitor cardiac output and identify fluid recruitable patients who may benefit from fluid administration.[20] [21] Mechanical ventilation causes cyclical alteration in left ventricular preload, more pronounced in hypovolemia. These cause SVV and pulse pressure variation, estimated by the arterial waveform. GDT using this cyclical variation in SVV and some technological assistance helps individualize and tailor the fluid therapy to each patient.[22] One such device is Flo Trac, an EV-1000 device used for the beat-to-beat analysis of hemodynamic status and cardiac output based on pulse contour analysis and respiratory variations in SVV.[23]

In our study, though less fluid was administered intraoperatively to patients receiving GDT compared with CFT, this difference was not statistically significant (p = 0.511). The results were consistent with studies by Ishihara et al in major abdominal surgery and Kaur et al in renal transplant surgery, which also reported a lower volume of intraoperative fluid administration in the GDT group, that was not significantly different from that of the CFT group.[24] [25] However, a few studies found a significant increase in fluid volume in the GDT group compared with the CFT group.[26] [27] This divergence may be due to differences in their study design, such as omission of vasopressor use in the GDT protocol or minimal differences between the fluid regimes.

In contrast, Diaper et al found a significant reduction in fluid volume in the GDT group compared with the CFT group, where echocardiographic data of the left ventricular outflow index were used to guide GDT.[27] Salzwedel et al, in their multicentric RCT, also found an increased absolute amount of fluid infused in the GDT group, with no statistically significant difference compared with the CFT group.[28] They preloaded patients with fluid before surgery. In contrast, the emergent nature of surgery in our study precluded preloading, instead intraoperative co-loading was followed. This might have resulted in comparable fluid volume in both groups. The fluid infused per body weight was also comparable and was less than that in other studies,[19] whereas fluid boluses were more in the GDT group. This is in contrast to studies in which fluid calculated per body weight showed a significant difference between GDT and CFT groups.[26] [27] GDT allows us to address hemodynamic derangements early, and this is done by following a structured algorithm to meet prespecified values. This might be a reason for the use of the increased amount of fluid boluses to meet these target values.

In our study, patients in the GDT group had less intraoperative blood loss and greater urine output in comparison to the CFT group, though not statistically significant. This led to less transfusion volume of PRBC and fewer episodes of hypotension. GDT protocol aims to prevent fluid overload and minimize blood hemodilution, leading to a decrease in blood loss, maintenance of coagulation factors, and improved perfusion as reflected with an increase in urine output and lower incidences of hypotension.[16] [19] [24]

DC involves extensive exposure of the cranium along with the scalp which invariably entails blood loss. Together with the underlying pathology of TBI, some amount of blood loss is therefore inevitable, resulting in a drop in hematocrit, even when using the GDT protocol. The significant drop in hematocrit at the end of surgery from that of baseline within the group might be a result of this. There was a statistically significant improvement in lactate levels in the GDT group from baseline and also between groups, signifying better perfusion in patients receiving GDT. The changes in hematocrit and lactate levels in our study are consistent with those reported in other perioperative neurosurgical studies as well.[18] [23] [28] [29] [30] The use of vasopressors and inotropes was similar in both groups, consistent with reports by Salzwedel et al.[28] However, the literature is diverse regarding the effect of GDT on the use of pharmacological agents to support hemodynamic. Ishihara et al reported an increase in its use, while others showed reduced use.[25] [26] [27] This variation may be related to different thresholds and choices for initiating vasopressor in these studies.

The mean FOUR score, ventilator, ICU, and hospital days, together with the mortality rate, were comparable between the groups. However, the study sample size might not be sufficiently powered for these secondary outcomes. These findings are similar to those of other studies, where ICU/ hospital stay and mortality had no difference. However, Peltoniemi et al found a significant difference in the length of stay in favor of GDT.[26]

Our study was the first of its kind comparing different fluid therapy protocols (GDT vs. CFT) in patients undergoing DC. However, this study has limitations. First, it is a single-center study that enrolled only DC patients. Thus, the result cannot be generalized to all TBI patients. Second, our GDT was based on arterial pulse contour analysis, the reliability of which diminishes in severe arrhythmias. Third, we protocolized intraoperative fluid therapy only. Hence, postoperative fluid choice might affect postoperative outcomes such as ICU stay. However, the study was also underpowered to study the long-term effects of fluid therapy. Hence, a multicentric and larger sample size study is required to translate the study results better and get a significant result, which may be sufficient to evaluate secondary outcomes.

Conclusion

GDT required a comparable intraoperative fluid volume. However, it resulted in fewer hypotension episodes and smaller falls in hematocrit, along with a more significant drop in lactate, compared with CFT in moderate to severe TBI patients undergoing early DC. However, other secondary neurological outcomes were comparable between the two study groups.

Conflict of Interest

None declared.

Note

This manuscript was presented at the 35th Annual Congress of the European Society of Intensive Care Medicine (ESICM LIVES 2022), held from October 22 to 26, 2022, in Paris, France.

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Publication History

Article published online:
27 February 2026