Protocol summary
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Study aim
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evaluating the effect of adding Octreotide to the treatment in reducing GI bleeding
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Design
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Randomized double blind placebo-controlled clinical trial
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Settings and conduct
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Fifty patients aged 0-15 years with gastrointestinal bleeding will be recruited in the study regarding inclusion and exclusion criteria. The patients will be admitted to Mofid children hospital and will receive the therapeutic dose of Pantoprazole, then will be randomly divided into two intervention and control groups; in the intervention group, patients will receive 1 to 2 μg / kg octreotide, and in the control group, placebo will be prescribed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: diagnosis of GI bleeding, age under 15 years, hemodynamic stability.
Exclusion criteria: abnormal levels of liver enzymes and bilirubin,
variceal gastrointestinal bleeding, a known case of gastrointestinal varices,
hepatomegaly or splenomegaly in the evaluation, chronic liver disease grade C in child pugh score.
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Intervention groups
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Intervention group: receiving the therapeutic dose of Pantoprazole and 1 to 2 μg / kg octreotide,
Control group: receiving the therapeutic dose of Pantoprazole and placebo.
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Main outcome variables
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hemoglobin range during treatment, need of receiving blood, rebleeding during hospitalization
General information
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Reason for update
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Due to delay in preparing the placebo and getting authorization for using the injectable placebo, the study conducted by about one year delay.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120415009475N6
Registration date:
2019-02-14, 1397/11/25
Registration timing:
prospective
Last update:
2020-07-06, 1399/04/16
Update count:
1
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Registration date
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2019-02-14, 1397/11/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2017-11-22, 1396/09/01
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Expected recruitment end date
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2018-04-21, 1397/02/01
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Actual recruitment start date
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2019-03-02, 1397/12/11
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Actual recruitment end date
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2019-12-31, 1398/10/10
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Trial completion date
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2020-01-31, 1398/11/11
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Scientific title
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Clinical trial for comparing standard treatment for non-variceal upper GI bleeding with and without Octreotide in pediatrics
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Public title
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comparing the effect of Octreotide on non-variceal GI bleeding in children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
diagnosis of GI bleeding
age under 15 years
hemodynamic stability
Exclusion criteria:
abnormal levels of liver enzymes and bilirubin
variceal gastrointestinal bleeding
Known case of gastrointestinal varices
Hepatomegaly or splenomegaly in evaluation
chronic liver disease grade C in child pugh score
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Age
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To 15 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
Actual sample size reached:
43
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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the randomization has been performed using the permuted block randomization table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The medication and placebo will be in look-alike coded packages, and the codes based on the permuted block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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All patients will be visited by a physician and patients' demographic characteristics including Age, Sex, weight, height, co-morbidities, and clinical findings including coagulation status, gastrointestinal disease history, endoscopic findings, hemoglobin range during treatment, need of receiving blood, and also dose and duration of treatment with octreotide will be recorded. Also, duration of hospitalization, patient outcome, re-bleeding during hospitalization, failure of treatment defined as a recurrence of bleeding or continuous bleeding during treatment will be recorded.
Ethics committees
1
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Ethics committee
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Approval date
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2017-07-01, 1396/04/10
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Ethics committee reference number
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IR.SBMU.PHNM.1396.734
Health conditions studied
1
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Description of health condition studied
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Gastrointestinal bleeding in children
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ICD-10 code
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K29.01
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ICD-10 code description
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Acute (erosive) gastritis with haemorrhage
Primary outcomes
1
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Description
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Stop gastrointestinal bleeding
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Timepoint
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every hour until bleeding stops
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Method of measurement
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gastric lavage
Secondary outcomes
1
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Description
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Need for blood transfusion
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Timepoint
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24 hours before until 48 hours after intervention
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Method of measurement
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Volume of blood infusion (milliliter per kilogram)
2
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Description
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hemoglobin level
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Timepoint
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daily during admission
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Method of measurement
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complete blood count
Intervention groups
1
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Description
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Intervention group: patients will receive 1 to 2 micrograms of Octreotide per kilogram of body weight per hour until the cessation of bleeding. Every 50 micrograms will be infused in 50 milliliters of normal saline as a one milliliter per kilogram weight per hour.
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Category
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Treatment - Drugs
2
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Description
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Control group: patients will receive placebo ampule in 50 milliliters of normal saline infused as a 1 milliliter per kilogram weight per hour until the cessation of bleeding.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The main outcome will be available.
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When the data will become available and for how long
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Six months after publishing data.
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To whom data/document is available
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The data will be available per request for people working in academic institutions.
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Under which criteria data/document could be used
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The data will available for using in systematic review and meta-analysis.
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From where data/document is obtainable
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The data will be available by contacting email; mirrahimi@sbmu.ac.ir.
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What processes are involved for a request to access data/document
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The data will available for using in systematic review and meta-analysis.
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Comments
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