Noradrenalin versus the combination of Midodrine and Octreotide in the treatment of patients with Hepatorenal syndrome type 1 and 2 referred to Alzahra Hospital since 2011 to 2012
Objectives: To assess the efficacy of Noradrenalin in comparison with the efficacy of the combination of Midodrine and Octreotide in the treatment of patients with Hepatorenal syndrome (HPS) type 1 and 2
Design: A single-blinded randomized clinical trial on patients with HPS type 1 and 2 referred to Alzahra Hospital (affiliated to Isfahan University of Medical Sciences) since 2011 to 2012.
Setting and conduct: Twenty two patients with HPS will divide into two groups randomly and will be treated with Noradrenalin or the combination of Midodrine and Octreotide. During the study, patients will be studied for renal and liver functions, continuous heart monitoring and urinary output measurement.
Participants including major eligibility criteria: Inclusion criteria: HPS… Exclusion criteria: Improvement of renal function after volume expansion; history of infection, nephrotoxic drug usage or volume loss in recent week; contraindication to Noradrenalin, Midodrine or Octreotide; recent history of gastrointestinal bleeding; severe hepatic encephalopathy; hepatocellular carcinoma; platelet counts lower than 25000 per microliters; international normalized ratio (INR) more than 5; acute coronary syndrome
Intervention: One group will be administered with the continuous infusion of Noradrenalin and the other group will be administered with the combination of oral Midodrine and intravenous infusion of Octreotide.
Main outcome measures variable: Systolic, diastolic and mean atrial pressure; central vein pressure; heart rate; urinary output; serum and urinary sodium; glomerular filtration rate; serum and urinary creatinine; serum bilirubin; serum urea; plasma activated renin; plasma aldosterone
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107217085N1
Registration date:2011-11-22, 1390/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-22, 1390/09/01
Registrant information
Name
kambiz yazdanpanah
Name of organization / entity
Meical university of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 4894
Email address
kyazdanpanah@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Reserch and Technology, Isfahan University of medical Sciences, Isfahan, Iran
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Noradrenalin versus the combination of Midodrine and Octreotide in the treatment of patients with Hepatorenal syndrome type 1 and 2 referred to Alzahra Hospital since 2011 to 2012
Public title
Noradrenalin versus Midodrin-Octerotid in Hepatorenal Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hepatorenal syndrom patients … Exclusion criteria: Improvement of renal function after volume expansion; history of infection, nephrotoxic drug usage or volume loss in recent week; contraindication to Noradrenalin, Midodrine or Octreotide; recent history of gastrointestinal bleeding; severe hepatic encephalopathy; hepatocellular carcinoma; platelet counts lower than 25000 per microliters; international normalized ratio (INR) more than 5; acute coronary syndrome
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2011-08-01, 1390/05/10
Ethics committee reference number
390210
Health conditions studied
1
Description of health condition studied
Hepatorenal Syndrome type 1 & 2
ICD-10 code
K76.7
ICD-10 code description
Hepatorenal Syndrome
Primary outcomes
1
Description
Serum ceatinine
Timepoint
Before the study and every day during the study
Method of measurement
laboratory method
Secondary outcomes
1
Description
Systolic and diastolic pressure
Timepoint
Before the study and every 4 hours during the study
Method of measurement
sphygmomanometer
2
Description
Urinary output
Timepoint
Before the study and every day during the study
Method of measurement
Collecting scaled bag
3
Description
Serum and urinary sodium
Timepoint
Before the study and every day during the study
Method of measurement
Laboratory method
4
Description
Glomerular filtration rate
Timepoint
Before the study and every day during the study
Method of measurement
Cockroft-Gault formula
Intervention groups
1
Description
One group is treated with Noradrenalin infusion of 0.1 microgram per kilogram. The dose is escalated every 4 hours by 0.05 microgram per kilogram up to the maximum dose of 0.7 microgram per kilogram or until 10 millimeter increase in the mean arterial pressure. The drug is continued until creatinine is reached less than 1.5 milligram per deciliter or until 15 days.
Category
Treatment - Drugs
2
Description
The other group is treated with Octereotide infusion of 25 microgram per hour and oral Midodrin of 5 milligram three times a day up to the maximum dose of 45 milligram per day or until Mean arterial pressure is increased by 15 millimeter. The treatment is continued until creatinine is reached less than 1.5 milligram per deciliter or 15 days is elapsed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Kambiz Yazdanpanah
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan 81744, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery for Reserch and Technology, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
390210
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Reserch and Technology, Isfahan University of Medical Sciences, Isfahan, Iran
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
Isfahan University of Medical Sciences
Full name of responsible person
Kambiz Yazdanpanah
Position
Fellowship of Gastroentrology and Hepatology
Other areas of specialty/work
Street address
Alzahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1669 4894
Fax
Email
kyazdanpanah@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Kambiz Yazdanpanah
Position
Fellowship of Gastroentrology and Hepatology
Other areas of specialty/work
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1669 4894
Fax
Email
kyazdanpanah@resident.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Kambiz Yazdanpanah
Position
Fellowship of Gastroentrology and Hepatology
Other areas of specialty/work
Street address
Alzahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1669 4894
Fax
Email
kyazdanpanah@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)