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

Phase 4

• Conditions: Acid-Base Balance Disorder
• Interventions: Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE

• Registration Number: NCT03115060
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• patients undergoing elective living donor renal transplant

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE	Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period
plasmalyte A	intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE	Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period
ringer lactate	intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE	Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
serum creatinine on day 1, 2 and 7 of surgery	day 1, 2 and 7	This is a function of kidney measure and will tell about the success of Renal Transplant
intraoperative hemodynamics in all patients	intraoperatively

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India