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

July 13, 2026 updated by: Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital

The Comparison Between Ringer Lactate Solution and Normal Saline With Dextrose Water in the First Week Post-Operative Period of Deceased Donor and Living Donor Kidney Transplantation

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 KTRs per arm will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 4 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Division of Nephrology, Faculty of Medicine, King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ringer lactate arm
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
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.
Active Comparator: Normal saline arm with dextrose water
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
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.
Other Names:
  • NSS + D5W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum bicarbonate level
Time Frame: Day 4 after transplantation
Day 4 after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum potassium level
Time Frame: Day 4 after transplantation
Day 4 after transplantation
Serum chloride level
Time Frame: Day 4 after transplantation
Day 4 after transplantation
Serum sodium level
Time Frame: Day 4 after transplantation
Day 4 after transplantation
Immune function marker
Time Frame: Day 4 after transplantation
TNF-alpha
Day 4 after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

February 24, 2026

Study Completion (Actual)

March 24, 2026

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUKT-FLUID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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