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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06030609
Acronym
RINNOR
Enrollment
159
Registered
2023-09-11
Start date
2024-09-01
Completion date
2026-03-24
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrolyte Imbalance, Kidney Transplant; Complications

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 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.

Interventions

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.

DRUGNormal 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.

Sponsors

King Chulalongkorn Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum bicarbonate levelDay 4 after transplantation

Secondary

MeasureTime frameDescription
Serum potassium levelDay 4 after transplantation
Serum chloride levelDay 4 after transplantation
Serum sodium levelDay 4 after transplantation
Immune function markerDay 4 after transplantationTNF-alpha

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026