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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115060
Recruitment Status : Unknown
Verified April 2017 by Dr Vikas Saini, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Vikas Saini, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Acid-Base Balance Disorder Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: normal saline
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
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

Experimental: ringer lactate
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
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

Experimental: plasmalyte A
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
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




Primary Outcome Measures :
  1. acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient [ Time Frame: during the surgery ]
    pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis


Secondary Outcome Measures :
  1. serum creatinine on day 1, 2 and 7 of surgery [ Time Frame: day 1, 2 and 7 ]
    This is a function of kidney measure and will tell about the success of Renal Transplant

  2. intraoperative hemodynamics in all patients [ Time Frame: intraoperatively ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing elective living donor renal transplant

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115060


Contacts
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Contact: Tanvir samra, MD Anaesthesia 7087008799 drtanvirsamra@yahoo.co.in

Locations
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India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: vikas saini    7087008119    drvsaini@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Dr Vikas Saini, Associate Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03115060    
Other Study ID Numbers: INT/IEC/2016/937
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions