Evaluation of effects of rapid infusion of normal saline during vessel anastomosis on graft function and acid base balance in kidney transplantation surgery
Introduction: Infusion of large volumes of normal saline (N/S) was recommended for facilitating graft function in kidney transplantation surgery but it can cause severe metabolic acidosis. This study is going to evaluate effects of rapid infusion of N/S during vessel anastomosis period on acid base, electrolytes and graft function.
Methods and materials: In a self-control clinical trial 30 candidates for reception of kidney from live donors are evaluating during kidney transplantation. Inclusion criteria are age 18 to 65 y/o, no previous kidney transplantation, ejection fraction more than 45% and exclusion criteria are bleeding more than 3cc/kg and vessel anomaly in donors kidney. During vessel anastomosis period Infusion of N/S is increasing from 10 ml/kg/h to 50 ml/kg/h and acid base balance, electrolytes and anion gap are measuring and comparing at the beginning and end of surgery. Serum creatinine and urine output till 48 hours after surgery are going to measure and analyze too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041516415N1
Registration date:2014-04-15, 1393/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of kidney transplantation of St Alzahra Hospital
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-09-30, 1393/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of rapid infusion of normal saline during vessel anastomosis on graft function and acid base balance in kidney transplantation surgery
Public title
Evaluation of effects of rapid infusion of normal saline during vessel anastomosis on graft function and acid base balance in kidney transplantation surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; end stage renal disease; candidate of elective live donor kidney transplantation; no previous kidney transplantation; no liver disease; ejection fraction more than 45%; ASA I and II
Exclusion criteria: Bleeding more than 3 ml/kg; vascular anomaly in donor kidney
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This is a self control study (condition of cases before intervention are using as control cases)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Isfahan, University boulevard, Isfahan university of medical sciences
City
Isfahan
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
391192
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 5
ICD-10 code
N18.5
ICD-10 code description
Chronic uraemia End stage kidney disease: in allograft failure NOS on dialysis without dialysis or transplant
Primary outcomes
1
Description
Anion Gap
Timepoint
Before and after fluid infusion
Method of measurement
Calculation of anion gap by measuring blood gas analysis and and blood electrolytes concentration