Pulse pressure variation guided goal-directed fluid therapy versus liberal fluid therapy in adult patients undergoing major emergency surgery: A randomized controlled trial

Background: Optimal intraoperative fluid management significantly improves postoperative outcomes, particularly in major surgeries. Fluid management in emergency surgeries is more challenging than in elective settings as mortality risk is approximately eightfold higher.  Widely used liberal fluid therapy (LFT), can lead to complications like fluid overload. Goal-directed fluid therapy (GDFT) is effective but often invasive and costly. Pulse Pressure Variation (PPV)-guided GDFT offers a minimally invasive and cost-effective alternative with the potential to reduce postoperative complications.

Objective: This study aims to compare the impact of intraoperative PPV-guided GDFT with conventional LFT on postoperative outcomes in adult patients undergoing major emergency surgeries.

Methods:

This single-centre, randomized, controlled, triple-blind, parallel-arm trial will be conducted at AIIMS Kalyani. A total of 62 patients will be randomly assigned to two groups (PPV-GDFT or LFT) in a 1:1 ratio using a computer-generated randomization table. Allocation will be concealed using sequentially numbered, sealed envelopes.

Inclusion criteria: Adults (18–65 years), ASA grades I–IV, undergoing emergency major surgeries under general anaesthesia.

Exclusion criteria: Patients presenting with bleeding emergencies requiring immediate life-saving surgical intervention, resuscitative laparotomy, ED thoracotomy, post-cardiac arrest status, Neurological emergency, Pregnancy, burn injuries, ASA V category, acute liver failure, Known coagulopathy or on anticoagulant therapy (unmanageable in a perioperative setting), Pre-existing severe cardiac dysfunction (ejection fraction <30%, severe cardiac arrhythmia, severe valvular disease, intracardiac shunt) and  Patients with terminal cancer needing palliative surgery or receiving regular renal replacement therapy.

Intervention:

LFT group: Balanced crystalloid (Plasmalyte) based on the Holliday–Segar formula, with adjustments for cumulative losses, blood loss, and urine output.

PPV-GDFT group: Balanced crystalloid to maintain PPV

12%.

In both groups, mean arterial pressure (MAP) >70 mmHg and urine output >0.5 mL/kg/hr will be maintained, with vasopressors administered if necessary.

Postoperative management will include maintaining urine output >0.5 mL/kg/hr and MAP >70 mmHg until patients resume oral intake. Excessive fluid balance (>1 L) will be managed with furosemide.

 Outcomes:

Primary outcome: Postoperative Sequential Organ Failure Assessment (SOFA) scores on days 1, 2, and 5.

Secondary outcomes: Intraoperative fluid balance, hypotension episodes, vasopressor use, postoperative serum lactate, serum albumin, C-reactive protein, complications (surgical/non-surgical), length of hospital stay, and mortality.

Statistical Analysis:

Data will be collected using a paper-based case report form and entered into Excel. Continuous data will be analyzed using Mann–Whitney or Student’s t-tests, and categorical data with Fisher’s exact test. Statistical significance will be set at P < 0.05.

Conclusion: This trial will assess whether PPV-guided GDFT provides superior outcomes compared to conventional LFT in major emergency surgeries.