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NCT Number: NCT07239713

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Military Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Brig. Syed Asadullah Jafri

CONTACT

+923212427770

Khadija Zubair, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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:

  • Does the choice of fluid produce different outcomes in this patient population?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. serum lactate

    Time frame: 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).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Khadija Dr. Zubair, MBBS

CONTACT

[email protected]

+923211403262

Sponsors and collaborators

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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