Comparing fluid therapy guided by PVI (Plethysmography Variability Index) monitoring vs. conventional fluid therapy in improving transplant kidney function and blood lactate levels in kidney transplant patients
In a prospective controlled double blinded clinical trial we try to find which method; PVI guided fluid therapy or conventional methods, helps keep kidney function better (as mesured by urine output) and prevents acidosis from worsening (as measured by serum lactate).
We select our patients from Kidney transplant recipients between 18 and 70 years old who are not cases of Known Cardiomyopathy; AF Rhythm; blood tranfusion during surgery; History of valve replacement surgery; Asthma or COPD; Morbid Obesity; EF<40%, Hb<7; Symptomatic coronary artery diseasse and prior kidney transplantation history.
Patients who develop arrhythmias during perioperative period or have a blood loss more than 1000cc are excluded from the study.
We use PVI monitoring to give fluids to patients during surgery and use known conventional liberal methods for the control group. We measure Urine volumes, Serum lactate, Hemodynamic measures (heart rate and Mean arterial pressure) and ABG factors during peri-operative period and kidney function 6 months after surgery to compare the newly discovered and non-invasive PVI monitoring to conventional more liberal methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072929116N1
Registration date:2016-12-07, 1395/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Fardad Iranidoust Haghighi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 2772
Email address
f-iranidoosth@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences. School of medicine
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing fluid therapy guided by PVI (Plethysmography Variability Index) monitoring vs. conventional fluid therapy in improving transplant kidney function and blood lactate levels in kidney transplant patients
Public title
Comparing fluid therapy for kidney transplant surgery guided by PVI (Plethysmography Variability Index) monitoring and conventional fluid therapy in improving transplant kidney function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Kidney transplant recipients between 18 and 70 years old who are not cases of known cardiomyopathy; AF rhythm; Blood tranfusion during surgery; History of valve replacement surgery; History of asthma or chronic obstructive pulmonary disease; Morbid obesity; EF<40%, Hb<7; Symptomatic coronary artery diseasse; Prior kidney transplantation history;
Exclusion criteria: peri-operative arrhythmias; peri-operative blood loss more than 1000cc;
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Individuals are assigned to control and intervention group randomly via a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences Medical Ethics Commitee
Street address
Tehran University Of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-04-04, 1395/01/16
Ethics committee reference number
IR.TUMS.REC.1395.2281
Health conditions studied
1
Description of health condition studied
End Stage Renal Failure
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease on dialysis
Primary outcomes
1
Description
Urine Volume
Timepoint
Before and after aortic declamping, 2hours after surgery, The day after surgery, 6 months after surgery
Method of measurement
Reading the Urine bag value
2
Description
Serum Lactate
Timepoint
Before and after aortic declamping, 2hours after surgery, The day after surgery, 6 months after surgery
Method of measurement
Arterial Blood Gas sample
Secondary outcomes
1
Description
Serum creatine
Timepoint
before surgery, The day after surgery
Method of measurement
Biochemistry Lab test
2
Description
Blood Urea Nitrogen
Timepoint
before surgery, The day after surgery
Method of measurement
Biochemistry Lab test
3
Description
Arterial Blood Gas (ABG)
Timepoint
before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery
Method of measurement
Arterial Blood Gas sampling
4
Description
Heart Rate per minute
Timepoint
before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery
Method of measurement
Pulse oximetry
5
Description
Blood Pressure (Mean Arterial Pressure)
Timepoint
before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery
Method of measurement
Non Invasive Blood Pressure monitoring
Intervention groups
1
Description
In the intervention group we use PVI monitoring (plethysmography variablility index) to administer fluids during kidney transplantation surgery.
We use the Masimo set PVI monitoring. Masimo, Irvine California.
We use the device to guide the peri-operative fluid therapy during the surgery in the operating room.
The PVI index is maintained between 10-13 by administering additional crystaloids. as the index rises above 13, 200 mililiters of crystaloids are adminstered and maintenance is given so that the index is always between 10 and 13. If the index is below 10, then all the crystaloids are held except half the maintenance need.
Category
Treatment - Other
2
Description
In the control group we administer fluids to the patients by the conventional liberal methods for transplant recipient patients. we give fluids freely to compensate for hemodynamic abnormalities and/or fluid loss and deficits and half the maintenance needs to the patients during surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Fardad Iranidoost Haghighi
Street address
Shariati Hospital, Jalal-e-ale ahmad St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhonzadeh
Street address
Poursina St. 16th Azar St. School of medicine. Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Fardad Iranidoost Haghighi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, Jalal-e-ale ahmad St, Tehran
City
Tehran
Postal code
-
Phone
+98 21 2235 2772
Fax
-
Email
drfardad@Gmail.comf-iranidoosth@TUMS.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Reza Atef Yekta
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shariati Hospital, Jalal-e-ale ahmad St, Tehran
City
Tehran
Postal code
-
Phone
+98 218490000
Fax
-
Email
rezaatefyekta@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Fardad Iranidoost Haghighi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, Jalal-e-ale ahmad St, Tehran
City
Tehran
Postal code
Phone
+98 21 2235 2772
Fax
-
Email
Drfardad@Gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)