Comparison of two methods of continuous infusion and bullous intermittent administration of IV Ranitidine on gastric PH in patients admitting to the surgical ICU
Propose: Comparison of two methods of continuous infusion and bullous intermittent administration of IV Ranitidine on gastric PH in patients admitting to the surgical ICU. Design and criteria: This study is prospective, randomize, Single blind and clinical trial, 70 patients were randomly divided into two groups of 35 patients ( The nurse was blind about the drug). Intervention group 1: Ranitidine 50 mg IV bolus injections at the first time and then three bolus doses were administered 50 mg every 8 hours for 24 hours.
.The second Intervention group received the ampoule for intravenous ranitidine 6/25 mg in the hours after the bolus injection 50 mg (at the time) used. Both groups received an equal amount of 200 mg of the drug.
Inclusion criteria: All patients aged over 18 years admitted to the ICU after surgery .Exclusion criteria: Pregnancy; H 2-blocker therapy for 8 hours before starting the study; treatment with antacids before starting the study; renal disease. Primary outcome: gastric PH (Before treatment and then every 2 hours for 24 hours was measured with PH measurements) and administration of ranitidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409178384N4
Registration date:2014-11-19, 1393/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-19, 1393/08/28
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical sciences
Expected recruitment start date
2013-08-11, 1392/05/20
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of continuous infusion and bullous intermittent administration of IV Ranitidine on gastric PH in patients admitting to the surgical ICU
Public title
Comparison of two methods of continuous infusion and bullous intermittent administration of IV Ranitidine on gastric PH
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All patients aged over 18 years admitted to the ICU after surgery. Exclusion criteria: Pregnancy; H 2-blocker therapy for 8 hours before starting the study; treatment with antacids before starting the study; renal disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
70
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2013-07-27, 1392/05/05
Ethics committee reference number
920252
Health conditions studied
1
Description of health condition studied
Gastric PH
ICD-10 code
K31.8
ICD-10 code description
Other specified diseases of stomach and duodenum
Primary outcomes
1
Description
Gastric PH
Timepoint
Before treatment and then every 2 hours for 24 hours.
Method of measurement
PH measurements
2
Description
Administration of ranitidine in intermittent bolus
Timepoint
In the first, then every 8 hours for 24 hours
Method of measurement
Intermittent bolus
3
Description
Administration of ranitidine as a continuous infusion
Timepoint
In the first then each hour
Method of measurement
Continuous infusion
4
Description
When the PH is upper than 4
Timepoint
Every 2 hours
Method of measurement
PH measurements
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ranitidine 50 mg IV bolus injections at the first time and then three bolus doses were administered 50 mg every 8 hours.
Category
Treatment - Drugs
2
Description
The second Intervention group received the ampoule for intravenous ranitidine 6/25 mg in the hours after the bolus injection 50 mg (at the time) used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Arash Peivandi Yazdi
Street address
Department of anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
peivandia@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
peivandia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
peivandia@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)