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

Acid-Base Balance Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03115060
• Other study ID #: INT/IEC/2016/937
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2017
• Last updated: May 12, 2017
• Start date: April 1, 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Tanvir samra, MD Anaesthesia
• Phone: 7087008799
• Email: drtanvirsamra[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients undergoing elective living donor renal transplant

Exclusion Criteria:

Related Conditions & MeSH terms

• Acid-Base Balance Disorder

Intervention

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

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	intraoperative hemodynamics in all patients		intraoperatively