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

Study Overview
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Brief Summary
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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.

Official Title
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The Comparison Between Ringer Lactate Solution and Normal Saline in the First Week Post-Operative Period of Deceased Donor and Living Donor Kidney Transplantation

Conditions
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Electrolyte Imbalance, Kidney Transplant; Complications

Intervention / Treatment
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* Drug: Ringer's Lactate Crystalloid Solutions
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ringer lactate arm<br>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. | Drug: Ringer's Lactate Crystalloid Solutions<br>* 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.<br>|
| Active Comparator: Normal saline arm<br>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. | Drug: Normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum bicarbonate level |  | Day 5 after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum potassium level |  | Day 5 after transplantation | 
| Serum chloride level |  | Day 5 after transplantation | 
| Immune function marker | TNF-alpha | Day 5 after transplantation |