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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Abdominal Surgery; Sepsis Abdominal
• Intervention / Treatment: Other: Ringer's Lactate Crystalloid Solutions; Other: Sterofundin (Bolus of crystalloids)

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khadija Dr. Zubair, MBBS; Phone Number: +923211403262; Email: dr.khadijazubair97@outlook.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • Combined military hospital lahore
      • Contact: Brig. Syed Asadullah Jafri; Phone Number: +923212427770
      • Principal Investigator: Khadija Zubair, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Underwent Abdominal Surgery and postoperative length of stay is more than 24 hours
• ASA 1 to 4
• Diagnosis of sepsis (qSOFA score 2 or more)

Exclusion Criteria:

• Patients with Renal failure/hepatic failure/severe metabolic acidosis
• Patients requiring renal replacement therapy prior to enrolment
• Patients with suspected poisoning
• Pregnant women
• Patients having solitary kidney

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ringer's Lactate Group; This group will receive RInger's Lactate as maintenance fluid.	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.
Experimental: Steroundin Group; This group will receive Sterofundin as maintenance fluid.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum lactate	Measurement: Serum lactate levels will be measured from blood samples. Method: Standard laboratory assays will be used to quantify lactate concentration. Purpose: To assess the effect of maintenance fluids (Ringer's Lactate vs. Sterofundin) on lactate clearance and tissue perfusion in septic adult patients following abdominal surgery. Units: mmol/L	Samples will be collected at baseline (preoperatively or immediately postoperatively) and at predefined intervals during the postoperative period (e.g., 24 and 48 hours after surgery).

Collaborators and Investigators

• Sponsor: CMH Lahore Medical College and Institute of Dentistry
• Investigators: Study Chair: Syed A Jafri, MBBS, Combined military hospital lahore

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sepsis; Fluid therapy; Postoperative; Abdominal Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Intraabdominal Infections; sterofundin
• Other Study ID Numbers: 563/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes