1. Home
  2. Approved trials
  3. » فارسی

Evaluation of hemodynamic effects of bicarbonate infusion in hemorrhagic shock

Protocol summary

Study aim
Determination of hemodynamic effects of bicarbonate infusion in patients with hemorrhagic shock
Design
A Study of clinical trials with control groups, and parallel groups,single blind, randomized ,phase 2 is on 40 patients.Software has been used for randomization
Settings and conduct
Patients who are candidates for orthopedic and spinal surgery at Sina Hospital in Tehran are randomly divided into two groups.This study is one blind , and patients are unaware of the type of intervention. following bleeding during surgery more than 500 ml and systolic blood pressure of less than 100 mmHg, the bicarbonate infusion is started at a rate of 5 cc /min in intervention group, blood transfusion began according to the results of blood gases and blood lactate levels. control group: Instead of bicarbonate, serum Ringer's infusion is started and blood transfusion is began according to the results of blood gases and blood lactate levels.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients with ASA I,II and III are candidates for orthopedic, neurosurgery, and vascular surgery. Their bleeding is more than 500 cc and after bleeding, they find a drop in blood pressure of less than 100 mm Hg and need a blood transfusion Exclusion Criteria: All patients with liver dysfunction, lung disorders such as COPD, and increased ICP
Intervention groups
Intervention group: In this group, by increasing bleeding and lowering blood pressure, bicarbonate infusion begins. ABG, blood lactate, and blood pressure tests are performed and blood transfusions are given according to their results. Control group: In this group, by increasing bleeding and lowering blood pressure, serum Ringer infusion begins. ABG, blood lactate, and blood pressure tests are performed and blood transfusions are given according to their results.
Main outcome variables
Blood pressure-Acidosis-Blood Lactate-

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130304012695N5
Registration date: 2020-07-04, 1399/04/14
Registration timing: registered_while_recruiting

Last update: 2020-07-04, 1399/04/14
Update count: 0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of hemodynamic effects of bicarbonate infusion in hemorrhagic shock
Public title
The effect of bicarbonate in increasing blood pressure in patients with hemorrhagic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients whose bleeding is more than 500 cc systolic blood pressure lower than 100 mm patients with ASA I,II,III who are candidates for orthopedic Hip surgery, neurosurgery, and vascular surgery. patients required to receive blood transfusions, patients with hemorrhagic shock
Exclusion criteria:
All patients with liver dysfunction lung disorders such as COPD increased ICP Patients who do not agree to participate in this study
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 3
Hip joint surgery has a lot of bleeding. The bicarbonate infusion raised blood pressure
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ،Tehran University of Medical Sciences
Street address
SinaHospital, ImamKhomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.213

Health conditions studied

1

Description of health condition studied
hemorrhagic shock
ICD-10 code
R57.1
ICD-10 code description
Hypovolemic shock

2

Description of health condition studied
Acidosis
ICD-10 code
E87.2
ICD-10 code description
Acidosis

Primary outcomes

1

Description
Lactic Acidosis
Timepoint
At the end of surgery
Method of measurement
Vein blood sample mg/dl

2

Description
blood pressure changes
Timepoint
After the start of bicarbonate or serum at minutes 3-6-9 12-15
Method of measurement
Through the artier line with Lidco device /mmgh

Secondary outcomes

1

Description
blood acidosis
Timepoint
At the end of transfusion
Method of measurement
Arterial blood sample

Intervention groups

1

Description
Intervention group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, sodium bicarbonate infusion started at a rate of 5 cc / minute intravenously and continue until the systolic blood pressure reaches 100 mm Hg,then reduce the rate of bicarbonate to 2 cc/ minute.If the bleeding increases to the tolerable limit level , in each patient transfusion is started .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood.
Category
Treatment - Drugs

2

Description
Control group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, Serum Ringer infusion starts at 15 ml / min. If the pressure does not rise after 10 minutes, the Nor adrenaline infusion begins.If the bleeding increases to the tolerable limit level in each patient, transfusion will start .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
Sina Hospital Hassan Abad sq, em mam khomini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital Imam Khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Imam khomeni St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeni St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared.
When the data will become available and for how long
Starting access after accepting by a valid scientific journal and publishing it
To whom data/document is available
For academic researchers and in the field of science
Under which criteria data/document could be used
All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned.
From where data/document is obtainable
Dr. Mohammad Reza Khajavi Email: khajavim@tums.ac.ir
What processes are involved for a request to access data/document
The applicant can request the type of files by email.
Comments
Loading...