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

NCT03115060 | Unknown Phase 4 DMC

• 1 other identifier: INT/IEC/2016/937
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Acid-Base Balance Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• serum creatinine on day 1, 2 and 7 of surgery

  day 1, 2 and 7

• intraoperative hemodynamics in all patients

  intraoperatively

Study Arms (3)

normal saline

EXPERIMENTAL

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

ringer lactate

EXPERIMENTAL

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

plasmalyte A

EXPERIMENTAL

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

Interventions

intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE DRUG

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

normal saline; plasmalyte A; ringer lactate

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing elective living donor renal transplant

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Interventions

Saline Solution; Plasmalyte A

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Tanvir samra, MD Anaesthesia

CONTACT

7087008799; drtanvirsamra@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 14, 2017
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 15, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)