Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation

Study Overview
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Brief Summary
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Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.

Official Title
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Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.

Conditions
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Acid-Base Balance Disorder

Intervention / Treatment
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* Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective living donor renal transplant Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normal saline<br>Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE<br>* intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention<br>|
| Experimental: ringer lactate<br>Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE<br>* intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention<br>|
| Experimental: plasmalyte A<br>Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period | Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE<br>* intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient | pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine on day 1, 2 and 7 of surgery | This is a function of kidney measure and will tell about the success of Renal Transplant | day 1, 2 and 7 | 
| intraoperative hemodynamics in all patients |  | intraoperatively |