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

NCT ID: NCT03115060

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-04-30

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.

Detailed Description

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Conditions

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Acid-Base Balance Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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normal saline

Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period

Group Type EXPERIMENTAL

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

Intervention Type 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

ringer lactate

Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period

Group Type EXPERIMENTAL

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

Intervention Type 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

plasmalyte A

Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective living donor renal transplant

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr Vikas Saini

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PGIMER

Chandigarh, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Tanvir samra, MD Anaesthesia

Role: CONTACT

7087008799

Facility Contacts

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vikas saini

Role: primary

7087008119

Other Identifiers

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INT/IEC/2016/937

Identifier Type: -

Identifier Source: org_study_id

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