Upper gastrointestinal bleeding is one of the common complications in patients who admit in hospital. The therapeutic cost effects are high due to drugs and procedures that use for patients. Proton pomp inhibitor such as pantoprazole is cardinal drug that prescribed for these patients. The aim was to compare the clinical effectiveness of two doses of infusional pantoprazole in peptic ulcer bleeding. By reduction the total dose of pantoprazole drug side effects and the therapeutic cost effects decrease. This study is a double blind clinical trial that enrolled patients with upper gastro intestinal bleeding. Patients are randomized in two groups 1) Patients who receive 80 mg pantoprazole as bolus dose and 8 mg per hour as maintenance dose for 72 hours; 2) Patients in this group receive 40 mg pantoprazole as bolus dose and 4 mg per hour as maintenance dose for 72 hours. Then patients follow up for one month. Any groups consist of 83 patients who participate in this study from 21-3-2011 to 21-9-2011. Exclusion criteria are consumption of NSAID, Corticosteroid and PPI in last week, multiple ulcers, malignant ulcer, cirrhotic patients with coagulopathy disorders. Primary outcomes are need for surgery, re-bleeding, drop of HB (hemoglobin)>2 units, duration of admission more than 5 days and mean units of blood transfused. Secondary outcomes are mortality rate and readmission with upper gastrointestinal bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202289160N1
Registration date:2012-04-15, 1391/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-15, 1391/01/27
Registrant information
Name
Noorodin Jamshydian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 1223 3920
Email address
jamshydian.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effects of high-dose and low-dose pantoprazole after endoscopy in patients with peptic ulcer bleeding
Public title
Assessment the therapeutic effect of pantoprazole in patients with gastrointestinal bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who admit and present signs and symptoms of upper gastrointestinal bleeding such as: 1-Vomits of blood or black material (Hematemesis), 2-Black and tarry stool (Melena), 3-The passage of bright red or blood from the rectum (Hematochesia), 4-Vertigo; light headness and hypotension. Exclusion criteria are: 1-Malignant ulcer; 2-Multiple ulcers; 3-Cirrhotic patient with coagulopathy or hemorrhagic varices; 4-Chronic Renal Failure (CRF); 5-Patients who admitted with gastrointestinal bleeding in last month; 6-Patients receive NSAID and Corticosteroid for underlying disease; 7-Patients under 16 years or upper 70 years;8-Patients who are treated with PPI (proton pomp inhibitor) in last week.
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
166
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
Ahvaz Jundishapur University of Medical Sciences
Street address
University City
City
Ahvaz
Postal code
Approval date
2011-12-24, 1390/10/03
Ethics committee reference number
Eth-52
Health conditions studied
1
Description of health condition studied
Upper gastro intestinal bleeding
ICD-10 code
k20-k31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum
Primary outcomes
1
Description
Mean units of blood transfusde
Timepoint
In period of admission
Method of measurement
Mean units of blood transfusde in period of admission
2
Description
Duration of admission more than 5 days
Timepoint
In period of admission
Method of measurement
This time evaluate from admission to discharge
3
Description
Need for surgery
Timepoint
In period of admission
Method of measurement
According to vital signs and hemodinamicaly status
4
Description
Rebleeding
Timepoint
In period of admission
Method of measurement
According to vital signs and hemodinamicaly status
Secondary outcomes
1
Description
Readmission due to upper gastrointestinal bleeding
Timepoint
First month after admission
Method of measurement
With take of history and hemodinamicaly status
2
Description
The mortality rate
Timepoint
First month of admission
Method of measurement
With take of history and hemodinamicaly status
Intervention groups
1
Description
Pantoprazole 80 mg bolus infusion followed by 8 mg/h intravenously as maintenance dose for 72 h after endoscopic treatment
Category
Treatment - Drugs
2
Description
Pantoprazole 80 mg bolus infusion followed by 4 mg/h intravenously as maintenance dose for 72 h after endoscopic treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Internal Medicine, Imam Khomeini Hospital
Full name of responsible person
Noorodin Jamshydian
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Azadegan Street, Shohada Square
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Feghi
Street address
University City,Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ahvaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Noorodin Jamshydian
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Azadegan Street, Shohada Square
City
Ahvaz
Postal code
Phone
+98 33 1223 3920
Fax
Email
jamshydian.n@ajums.ac.ir , noorejam1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abdolarahem Masjedizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Azadegan Street, Shohada Square
City
Ahvaz
Postal code
61936-73166
Phone
+98 61 1222 2114
Fax
Email
rmasjedi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Noorodin Jamshydian
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Azadegan Street, Shohada Square
City
Ahvaz
Postal code
61936-73166
Phone
+98 61 1222 2114
Fax
+98 61 1222 5763
Email
jamshydian.n @ajums.ac.ir
Web page address
noorejam1@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)