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

Kidney Transplant; Complications Clinical Trial

— RINNOR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06030609
• Other study ID #: CUKT-FLUID
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Suwasin Udomkarnjananun, MD, PhD
• Phone: +66899679885
• Email: suwasin.u[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electrolyte Imbalance
• Kidney Transplant; Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum bicarbonate level		Day 5 after transplantation
Secondary	Serum potassium level		Day 5 after transplantation
Secondary	Serum chloride level		Day 5 after transplantation
Secondary	Immune function marker	TNF-alpha	Day 5 after transplantation