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

King Chulalongkorn Memorial Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Kidney Transplant; Complications; Electrolyte Imbalance

Treatments: Drug: Ringer's Lactate Crystalloid Solutions; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06030609

CUKT-FLUID

Details and patient eligibility

About

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 KTR will be enrolled and randomized to receive either RLS or NSS with D5W. 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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Ringer lactate arm

Experimental group

Description:

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.

Treatment:

Drug: Ringer's Lactate Crystalloid Solutions

Normal saline arm with dextrose water

Active Comparator group

Description:

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.

Treatment:

Drug: Normal saline