Post Abdominal Surgery, Sepsis Abdominal
Conditions
Keywords
Fluid therapy, Abdominal Surgery, Postoperative, Sepsis
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.
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
A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients.
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.
Sponsors
CMH Lahore Medical College and Institute of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum lactate | 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 |
Countries
Pakistan
Contacts
STUDY_CHAIRSyed A Jafri, MBBS
Combined military hospital lahore
Outcome results
None listed