Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ringer's Lactate Crystalloid Solutions, Sterofundin (Bolus of crystalloids).
- Who it may be relevant to
- Registry conditions: Post Abdominal Surgery, Sepsis Abdominal. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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).]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Combined Military Hospital Lahore — Lahore
Identifiers
NCT: NCT07239713 · 563/2024