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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Serum bicarbonate level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Ringer's Lactate Crystalloid Solutions (Drug)
Normal saline arm with dextrose water
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.
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Serum bicarbonate level
Time Frame: Day 5 after transplantation
Serum bicarbonate level
Time Frame: Day 4 after transplantation
Secondary Outcomes
- Serum potassium level(Day 5 after transplantation)
- Serum chloride level(Day 5 after transplantation)
- Immune function marker(Day 5 after transplantation)
- Serum potassium level(Day 4 after transplantation)
- Serum chloride level(Day 4 after transplantation)
- Serum sodium level(Day 4 after transplantation)
- Immune function marker(Day 4 after transplantation)
Investigators
Suwasin Udomkarnjananun
Assistant Professor
King Chulalongkorn Memorial Hospital