RINNOR: The Comparison Between Ringer Lactate Solution and Normal Saline in Post-Operative Period of Kidney Transplantation

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06030609

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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) on the electrolyte abnormality of kidney transplant recipients (KTR) during the first post-operative week. The problem with using NSS 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Electrolyte Imbalance Kidney Transplant; Complications	Drug: Ringer's Lactate Crystalloid Solutions Drug: Normal saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

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 The patient will receive NSS 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 as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.

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

The patient will receive NSS 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 as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.

Outcome Measures

Primary Outcome Measures

Serum bicarbonate level [Day 5 after transplantation]

Secondary Outcome Measures

Serum potassium level [Day 5 after transplantation]
Serum chloride level [Day 5 after transplantation]
Immune function marker [Day 5 after transplantation]
TNF-alpha

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suwasin Udomkarnjananun, Associate Professor, King Chulalongkorn Memorial Hospital

ClinicalTrials.gov Identifier:

NCT06030609

Other Study ID Numbers:

CUKT-FLUID

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 11, 2023