Ringer's lactate versus Sterofundin/PlasmaLyte for maintenance fluids in septic patients after abdominal surgery
Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients
This trial will test whether Ringer's lactate or Sterofundin/PlasmaLyte is better as a maintenance IV fluid for adults who develop sepsis after abdominal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | CMH Lahore Medical College and Institute of Dentistry Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07239713 on ClinicalTrials.gov |
What this trial studies
Adults who have undergone abdominal surgery and meet sepsis criteria (qSOFA ≥2) are randomly assigned to receive either Ringer's lactate or Sterofundin/PlasmaLyte as maintenance intravenous fluid for 72 hours. Treating clinicians determine the infusion volume, rate, and any additives, and patients are followed closely during the first 72 postoperative hours. The primary outcome is change in serum lactate; secondary outcomes include renal function measures, qSOFA scores, and incidence of postoperative complications within 72 hours. The trial is conducted at a single tertiary care center in Lahore, Pakistan.
Who should consider this trial
Good fit: Adults who had abdominal surgery with a postoperative stay over 24 hours, meet sepsis criteria (qSOFA ≥2), are ASA class 1–4, and do not have preexisting exclusion conditions are the intended participants.
Not a fit: Patients with renal or hepatic failure, severe metabolic acidosis, prior need for renal replacement therapy, suspected poisoning, solitary kidney, or pregnancy are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the trial could identify which balanced crystalloid better lowers lactate and reduces early complications in septic postoperative patients, guiding safer fluid choice.
How similar studies have performed: Large trials comparing balanced crystalloids to normal saline have shown modest renal and outcome benefits, but direct randomized comparisons between Ringer's lactate and Sterofundin/PlasmaLyte in septic postoperative patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lahore, Punjab Province
- Combined Military Hospital Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Khadija Dr. Zubair, MBBS
- Email: dr.khadijazubair97@outlook.com
- Phone: +923211403262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.