NCT07239713

Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis

Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: CMH Lahore Medical College and Institute of Dentistry · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/ Plasmalyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic. The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.

Detailed description

The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/PlasmaLyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic. The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery. The main questions it aims to answer are: 1. Does the choice of fluid produce different outcomes in this patient population? 2. If yes, then which fluid produces better outcomes? Enrolled patients will be randomly assigned Ringer's Lactate or Sterofundin for intravenous infusion. The volume, infusion rate and additive content will be determined by the treating clinicians. The intervention will last for 72 hours after patients' enrolment.

Conditions

• Post Abdominal Surgery
• Sepsis Abdominal

Interventions

Type	Name	Description
OTHER	Ringer's Lactate Crystalloid Solutions	A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients.
OTHER	Sterofundin (Bolus of crystalloids)	A balanced, multi-electrolyte crystalloid solution containing acetate and malate as buffers instead of lactate. Designed to more closely match plasma electrolyte composition, with a lower chloride concentration than RL.

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-05-15
• Completion: 2026-06-15
• First posted: 2025-11-20
• Last updated: 2025-12-16

Locations

1 site across 1 country: Pakistan