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

NCT07239713 | Recruiting

• 1 other identifier: 563/2024
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis Abdominal; Post Abdominal Surgery

Keywords

Fluid therapy; Abdominal Surgery; Postoperative; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Ringer's Lactate Group

ACTIVE COMPARATOR

This group will receive RInger's Lactate as maintenance fluid.

Other: Ringer's Lactate Crystalloid Solutions

Steroundin Group

EXPERIMENTAL

This group will receive Sterofundin as maintenance fluid.

Other: Sterofundin (Bolus of crystalloids)

Interventions

Ringer's Lactate Crystalloid Solutions OTHER

A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients.

Ringer's Lactate Group

Sterofundin (Bolus of crystalloids) OTHER

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.

Steroundin Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

Combined Military Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Intraabdominal Infections; Sepsis

Interventions

sterofundin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Syed A Jafri, MBBS

  Combined military hospital lahore

  STUDY CHAIR

Central Study Contacts

Khadija Dr. Zubair, MBBS

CONTACT

+923211403262; dr.khadijazubair97@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)