Optimal perioperative fluid management remains a cornerstone of enhanced recovery in major surgery, aiming to maintain adequate tissue perfusion while avoiding volume overload and its consequences [1]. Goal‑directed fluid therapy (GDFT), which relies on dynamic hemodynamic targets such as stroke volume variation and cardiac index, has been increasingly studied as a strategy to individualize fluid administration and mitigate postoperative complications [2].

In non‑cardiac surgical populations, systematic reviews and randomized controlled trials demonstrate that perioperative GDFT reduces postoperative morbidity—including renal, pulmonary, and infectious complications—and shortens hospital length of stay, though mortality benefits are less consistent [2,3]. Specifically, perioperative GDFT has been associated with significantly decreased rates of pneumonia and acute kidney injury compared with standard fluid care [3,4].

Evidence in patients undergoing cardiac surgery is more limited but promising. A meta-analysis of randomized controlled trials in this population found that GDFT significantly lowered postoperative complication rates (odds ratio ~0.33) and reduced hospital stay by approximately 2.4 days, although mortality remained unaffected [5]. Furthermore, a randomized clinical trial in high‑risk cardiac surgical patients targeting cardiac index demonstrated fewer major complications, shorter ICU and hospital stays, and reduced incidence of low cardiac output syndrome and infections [6].

However, most cardiac surgery trials combine various surgical types, and few focus on specific procedures such as valvular heart surgery. Considering the unique hemodynamic challenges and potential for fluid shifts in valvular procedures, there is a need for procedure‑specific evaluation of GDFT strategies. Against this background, the present study was undertaken to assess whether GDFT improves postoperative outcomes in patients undergoing elective valvular heart surgery under cardiopulmonary bypass.

Study Design: This prospective, randomized, controlled clinical trial was conducted at a tertiary care center in India.

Study Population: Patients aged between 18 and 65 years scheduled for elective valvular heart surgery under cardiopulmonary bypass (CPB) were considered eligible for inclusion. All participants provided written informed consent before enrolment. Patients with pre-existing renal dysfunction (serum creatinine >2.0 mg/dL), severe hepatic impairment, left ventricular ejection fraction (LVEF) <30%, or those undergoing emergency or redo surgeries were excluded from the study.

Randomization and Group Allocation: Eligible participants were randomly assigned into two groups using a computer-generated random number table and sealed opaque envelope technique:

Group G (Goal-Directed Therapy Group): Received intraoperative fluid management guided by dynamic hemodynamic parameters.

Group C (Conventional Group): Received standard fluid therapy based on static parameters and clinical judgment.

Anesthetic and Surgical Management: All patients underwent standardized general anesthesia induction and maintenance protocols. Monitoring included ECG, invasive arterial pressure, central venous pressure (CVP), pulse oximetry, urine output, and core temperature. Transesophageal echocardiography (TEE) and cardiac output monitoring devices such as FloTrac/Vigileo (Edwards Lifesciences) or equivalent were used in the GDFT group to measure stroke volume variation (SVV), cardiac index (CI), and stroke volume (SV).

Fluid boluses (250 mL of crystalloid over 10–15 min) were administered in the GDFT group if SVV exceeded 13%, with reassessment after each bolus. Vasopressors or inotropes were added as required to maintain mean arterial pressure (MAP) between 65–80 mmHg and CI >2.2 L/min/m².

In the conventional group, fluid administration was guided by CVP values (target: 8–12 mmHg), MAP, and urine output.

Postoperative Management and Follow-up: Postoperative care was provided in a dedicated cardiac ICU. Hemodynamic monitoring, fluid balance, ventilatory support, and laboratory parameters were recorded for the first 48 hours. Data collected included duration of mechanical ventilation, ICU stay, postoperative complications (e.g., arrhythmias, renal dysfunction, low cardiac output syndrome), and 30-day mortality.

Primary and Secondary Outcomes: The primary outcome was the duration of mechanical ventilation. Secondary outcomes included total intraoperative fluid administered, incidence of acute kidney injury (AKI), duration of ICU stay, length of hospital stay, and postoperative complications.

Statistical Analysis: Sample size was calculated based on anticipated reduction in mechanical ventilation duration with α = 0.05 and power = 80%, resulting in 56 patients per group. Data were analyzed using SPSS version 26.0. Continuous variables were expressed as mean ± standard deviation (SD) or median (IQR), and categorical variables as frequencies or percentages. Student’s t-test or Mann–Whitney U test was used for continuous variables and Chi-square or Fisher’s exact test for categorical data. A p-value <0.05 was considered statistically significant.

A total of 112 patients scheduled for elective valvular heart surgery were enrolled and randomized equally into two groups: Group G (goal-directed fluid therapy) and Group C (conventional fluid therapy), with 56 patients in each group. The baseline demographic and clinical characteristics, including age, gender distribution, body mass index (BMI), left ventricular ejection fraction (LVEF), prevalence of hypertension, diabetes mellitus, and NYHA functional class, were comparable between the two groups, indicating successful randomization (Table 1).

Table 1: Baseline Demographic and Clinical Characteristics

Intraoperatively, both groups had similar surgical durations and cardiopulmonary bypass times. However, Group G received significantly lower total fluid volumes and demonstrated higher urine output compared to Group C, indicating more efficient volume management. The frequency of intraoperative blood transfusion did not differ significantly between the groups (Table 2).

Table 2: Intraoperative Variables

Postoperative outcomes favored the goal-directed therapy group. Patients in Group G experienced a significantly shorter duration of mechanical ventilation, reduced ICU stay, and shorter overall hospitalization. Additionally, they exhibited a more favorable postoperative fluid balance and a lower requirement for prolonged inotropic support beyond 24 hours (Table 3).

Table 3: Postoperative Outcomes

The incidence of postoperative complications, particularly acute kidney injury, was significantly lower in Group G. Other complications, including arrhythmias, reintubation, surgical site infection, low cardiac output syndrome, and 30-day mortality, were numerically less frequent in the GDFT group, although these differences did not reach statistical significance (Table 4).

Table 4: Postoperative Complications

In this randomized study of valvular heart surgery patients, our findings align with broader evidence that GDFT facilitates enhanced clinical recovery. Notably, systematic evidence from recent meta‑analytic studies indicates that GDFT protocols guided by minimally invasive monitors such as the FloTrac system can significantly decrease the durations of mechanical ventilation, ICU stay, and overall hospitalization among adults undergoing major surgery, albeit without a corresponding mortality benefit [7].

Our results also resonate with prior cardiac surgery research reporting a reduction in acute kidney injury (AKI) associated with postoperative GDFT protocols. Specifically, observational and randomized data suggest targeting optimized cardiac output and dynamic assessments of fluid status may reduce AKI risk in high-risk surgical cohorts [8]. In the current study, the lower incidence of AKI in the GDFT group compares favorably with these prior findings and supports the notion that fine-tuned hemodynamic management mitigates renal insult.

Moreover, evidence from cardiac surgery literature emphasizes that postoperative goal-directed interventions—particularly those initiated early and maintained through the immediate recovery period—can reduce ICU and hospital length of stay and AKI rates [7]. The intraoperative application of GDFT in our study appears to produce comparable effects, suggesting efficacy extends beyond postoperative protocols into the intraoperative phase when fluid responsiveness is monitored continuously.

Beyond renal outcomes, our observed reductions in ventilation time, ICU and hospital stays mirror results seen in other surgical settings, including oncologic surgery, where recent meta-analysis demonstrates consistent benefits of intraoperative GDFT in reducing postoperative morbidity and hospitalization [9-12]. Combined with lower postoperative fluid overload and inotropic requirements, these benefits underscore how dynamic, individualized administration may stabilize hemodynamics more effectively than conventional approaches.

Limitations in this study include the inability to blind care providers to the protocol and reliance on a single-center population. Future research should examine longer-term outcomes, cost-effectiveness, and application across varied surgical subtypes. Nonetheless, our findings extend procedural-specific evidence for valvular heart surgery, indicating that intraoperative GDFT improves recovery and reduces select morbidities in this high-risk patient group.

GDFT was associated with improved postoperative outcomes in patients undergoing valvular heart surgery. Compared to conventional fluid management, GDFT led to a significant reduction in mechanical ventilation duration, ICU stay, and total hospital stay. The approach also resulted in lower intraoperative fluid administration and a reduced incidence of acute kidney injury. Although some postoperative complications showed no statistically significant difference, their overall frequency was lower in the GDFT group. These findings support the incorporation of GDFT into routine intraoperative management to enhance recovery and reduce complications in valvular cardiac surgery patients.

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