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

CMH Lahore Medical College and Institute of Dentistry

Status: Enrolling

Conditions: Sepsis Abdominal; Post Abdominal Surgery

Treatments: Other: Sterofundin (Bolus of crystalloids); Other: Ringer's Lactate Crystalloid Solutions

Study type: Interventional

Funder types: Other

Identifiers

NCT07239713

563/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Ringer's Lactate Group

Active Comparator group

Description:

This group will receive RInger's Lactate as maintenance fluid.

Treatment:

Other: Ringer's Lactate Crystalloid Solutions

Steroundin Group

Experimental group

Description:

This group will receive Sterofundin as maintenance fluid.

Treatment:

Other: Sterofundin (Bolus of crystalloids)