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Lasix effect in two ways at once and infusion therapy in patients with a kidney transplant in Imam Reza Hospital Tabriz

Protocol summary

Summary
Clinical trial study will be carried out. 80 Patients, who have had kidney transplant indications, received dialysis 24 hours preoperatively. Biochemical tests were done and recorded in information form, together with individual characteristics. Patients were divided into two groups, each with 40 patients. Then, each patient received a code and assigned to a group, based on a protocol that determines which code will receive which treatment regimen. One group was named the “Lasix bolus Group” and the other was named the “infusion Lasix”. The bolus dose was initiated within immediately one minute before arterial de-clamping. Infusion was initiated within 30 minutes before arterial de-clamping. Following arterial and venous anastomosis, ureter clamp taking time was checked and recorded in patient’s information form. Diuresis initiation time will be recorded in the samples studied. Finally, urinary output volume was measured until an hour after anastomosis and after each 3 hours for 24 hours, and then in second and third days in ward. Diuresis times in both groups will be determined and compared with each other. The person in charge of measuring will be unaware of Lasix administration method. In addition, the levels of sodium, potassium, BUN, and creatinine will be recorded preoperatively and postoperatively for 4 days.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042023559N3
Registration date: 2016-08-26, 1395/06/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-26, 1395/06/05
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lasix effect in two ways at once and infusion therapy in patients with a kidney transplant in Imam Reza Hospital Tabriz
Public title
Lasix effect in kidney transplant patients
Purpose
Treatment
Inclusion/Exclusion criteria
Included criteria: diagnosis of ESRD, indicated for kidney transplants; admission in Tabriz Imam Reza Hospital; male and female gender; 15-65 years old. Excluded criteria: patients with severe psychiatric problems; metastatic cancer patients; patients over 65 years old; patients with hemodynamic changes following their transplantation (reducing blood pressure less than 50 / 80 for more than half an hour); the constant drug abuse; chronic liver disease; reversible urinary tract infections; anomalies of the urinary system; aeortoiliac disease.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, University Avenue,
City
Tabriz
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.REC.TBZMED.1394.1141

Health conditions studied

1

Description of health condition studied
Kidney transplant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The volume of urine output
Timepoint
After vascular anastomosis to an hour, then every three hours for 24 hours then the second and third day after kidney transplant
Method of measurement
milliliter

Secondary outcomes

1

Description
Na
Timepoint
Before surgery and then daily until 4 days after kidney transplant
Method of measurement
meq/ml

2

Description
K
Timepoint
Before surgery and then daily until 4 days after kidney transplant
Method of measurement
meq/ml

3

Description
BUN
Timepoint
Before surgery and then daily until 4 days after kidney transplant
Method of measurement
mg/dl

4

Description
Creatinine
Timepoint
Before surgery and then daily until 4 days after kidney transplant
Method of measurement
mg/dl

Intervention groups

1

Description
Bolus injection (one minute immediately before declamping arteries) Lasix during kidney transplant surgery.
Category
Treatment - Drugs

2

Description
Infusion injection(over 30 minutes immediately before declamping arterial) Lasix during kidney transplant surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kidney transplant ward, The Imam Reza Hospital Tabriz
Full name of responsible person
Street address
The Imam Reza Hospital Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi M.D. Deputy of Research and Technology
Street address
Vice Chancellor for Research and Technology, University of Medical Sciences, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Professor Afshar Zomorrodi
Position
Professor of Urology
Other areas of specialty/work
Street address
Department of Urology, Imam Reza Hospital, University Street
City
Tabriz
Postal code
Phone
+98 41 3555 3407
Fax
Email
dr_afshar@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ismail Khanlari
Position
Resident of Urology
Other areas of specialty/work
Street address
Sharif building, western second 10 meters, Elahi Parast alley
City
Tabriz
Postal code
Phone
+98 41 3329 6594
Fax
Email
dr.esmaeilkhanlari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amin Bagheri
Position
Resident of Urology
Other areas of specialty/work
Street address
University Street, Imam Reza Hospital
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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