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

NCT06030609 | Completed Phase 3

• 1 other identifier: CUKT-FLUID
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Electrolyte Imbalance; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Serum bicarbonate level

  Day 5 after transplantation

Secondary Outcomes (3)

• Serum potassium level

  Day 5 after transplantation

• Serum chloride level

  Day 5 after transplantation

• Immune function marker

  Day 5 after transplantation

Study Arms (2)

Ringer lactate arm

EXPERIMENTAL

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.

Drug: Ringer's Lactate Crystalloid Solutions

Normal saline arm with dextrose water

ACTIVE COMPARATOR

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.

Drug: Normal saline

Interventions

Ringer's Lactate Crystalloid Solutions DRUG

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.

Ringer lactate arm

Normal saline DRUG

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.

Also known as: NSS + D5W

Normal saline arm with dextrose water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• multiorgan transplantation
• Known allergy to RLS or NSS

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Division of Nephrology, Faculty of Medicine, King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 11, 2023
• Study Start: September 1, 2024
• Primary Completion: December 24, 2025
• Study Completion: March 24, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

TH (1)