The Comparison Between Ringer Lactate Solution and Normal Saline with Dextrose Water in Post-Operative Period of Kidney Transplantation

Phase 3

Recruiting

• Conditions: Electrolyte Imbalance; Kidney Transplant; Complications
• Interventions: Drug: Ringer's Lactate Crystalloid Solutions; Drug: Normal saline

• Registration Number: NCT06030609
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief Summary

This is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of Ringer lactate solution (RLS) and normal saline solution (NSS) with dextrose water (D5W) on the electrolyte abnormality of kidney transplant recipients (KTR) during the first post-operative week. The problem with using NSS with or without D5W as a standard replacement fluid is the hyperchloremic metabolic acidosis which might compromise the kidney allograft function. A total 60 KTR will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-11
• Study Start: 2024-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A kidney transplant recipient who receives transplant at King Chulalongkorn Memorial Hospital.
• Age >=18 years
• Both deceased donor and living donor kidney transplantation will be included

Exclusion Criteria

• multiorgan transplantation
• Known allergy to RLS or NSS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer lactate arm	Ringer's Lactate Crystalloid Solutions	The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
Normal saline arm with dextrose water	Normal saline	The patient will receive NSS with D5W as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.

Primary Outcome Measures

Name	Time	Method
Serum bicarbonate level	Day 5 after transplantation

Secondary Outcome Measures

Name	Time	Method
Serum potassium level	Day 5 after transplantation
Serum chloride level	Day 5 after transplantation
Immune function marker	Day 5 after transplantation	TNF-alpha

Trial Locations

Locations (1)

Division of Nephrology, Faculty of Medicine, King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand