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Completed

NCT Number: NCT06030609

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: NSS + D5W

Primary outcomes

  1. Serum bicarbonate level

    Time frame: Day 4 after transplantation

Secondary outcomes

  1. Serum potassium level

    Time frame: Day 4 after transplantation

  2. Serum chloride level

    Time frame: Day 4 after transplantation

  3. Serum sodium level

    Time frame: Day 4 after transplantation

  4. Immune function marker

    Time frame: Day 4 after transplantation

    TNF-alpha

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study title

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

Acronym: RINNOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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