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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCMH Lahore Medical College and Institute of Dentistry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients with Renal failure/hepatic failure/severe metabolic acidosis

Patients requiring renal replacement therapy prior to enrolment

Patients with suspected poisoning

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ringer's Lactate Crystalloid Solutions

    Other intervention

    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 intervention

    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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Ringer's Lactate GroupActive comparator 1 intervention
Group B: Steroundin GroupExperimental treatment 1 intervention

Trial outcomes

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

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).

Secondary outcomes

Other outcomes

Sponsors and contacts

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