Investigating the effect of high-dose nitroglycerin injection in patients with acute pulmonary edema
Design
The intervention group received high-dose TNG (100 microgram/minute can be repeated every 3 to 5 minutes until the symptoms improve or the systolic blood pressure drop is less than 90 mm Hg) and the control group received the drug with the standard protocol (0.4 mcg/kg/min repeated). The drug will be given every 5 minutes until the clinical symptoms improve or the systolic blood pressure drops below 90 mmHg. First, based on the table of random numbers, codes are assigned to each patient, which are placed in equal numbers inside closed envelopes. The nurse responsible for prescribing the drug was not aware of the conditions of the prescription until the time of opening the envelope. After prescribing, he/she writes the envelope code on the checklist designed for the study, and the emergency medicine assistant completes the checklist for the patient without knowing how much medicine has been prescribed (the prescription is done under the supervision of the attending physician). For blinding, TNG is administered with a continuous pump, which is covered at the time of evaluation, blinding is considered for the researcher, the emergency medicine assistant, and the patient.
Settings and conduct
This study will done in the Emergency and Cardiology Department of Emereza and Ghaem hospital of Mashhad.
Participants/Inclusion and exclusion criteria
All patients between 18 and 65 years of age, referred to the emergency department with a complaint of dyspnea, for whom the diagnosis of acute pulmonary edema was made by clinical evidence, paraclinical findings, and imaging, were included in the study.
Intervention groups
Patients who have received high-dose TNG for Pulmonary edema.
Main outcome variables
Reduce blood pressure and patient dyspnea during the first 1-hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058465N2
Registration date:2024-06-20, 1403/03/31
Registration timing:registered_while_recruiting
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Islamic Republic of Iran Vafadar moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
vafadarme@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-03-11, 1402/12/21
Expected recruitment end date
2026-03-18, 1404/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high-dose nitroglycerin injection in patients with acute pulmonary edema
Public title
The effect of high-dose nitroglycerin injection in patients with acute pulmonary edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chief complaint of dyspnea due to decompensated heart failure vascular type ( orthopnea, fine crackle on auscultation, raised JVP)
Exclusion criteria:
hypotension
recent myocardial infarction
history of allergy to TNG
patients who need intubation on admission
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple block using random Allocation software version 1.0.0, we set the block size to four, with two in the high dose nitroglycerine and two in routine dose.
Blinding (investigator's opinion)
Triple blinded
Blinding description
First, based on the table of random numbers, codes are assigned to each patient, which are placed in equal numbers inside closed envelopes. The nurse responsible for prescribing the drug was not aware of the conditions of the prescription until the time of opening the envelope. After prescribing the medicine, he/she writes the envelope code on the checklist designed for the plan, and the emergency medicine assistant completes the checklist for each patient without knowing how much medicine has been prescribed (the prescription is done under the supervision of the attending physician).
For blinding, TNG is administered with a continuous pump, which is covered at the time of evaluation, blinding is considered for the researcher, the emergency medicine assistant, and the patient.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, TNG was administered with a higher dose than usual in patients with decompensated heart failure.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad
Street address
Emam reza hospital, Razi sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MUMS.IRH.REC.1403.002
Health conditions studied
1
Description of health condition studied
Decompensated Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Reduce blood pressure and dyspnea
Timepoint
q 5 minutes up to 1-hour
Method of measurement
For blood pressure use mmHg, and for reduce dyspnea use Likert scale
Secondary outcomes
1
Description
Intubation
Timepoint
1-hour after admission
Method of measurement
Intubation
Intervention groups
1
Description
Receive high dose TNG(100 micro per minute)
Category
Treatment - Drugs
2
Description
Receive usual TNG( 4 micro per minute)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza Hospital
Full name of responsible person
Dr. Behgam Fatehi
Street address
Razi sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Emamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tafaghodi
Street address
Ghoreishi building, Daneshgah Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Vafadar Moradi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emam reza Hospital, Razi sq., mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Vafadarme@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Vafadar Moradi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
EmamReza Hospital, Razi sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
009838543031
Email
VafadarME@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Vafadar Moradi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Razi sq
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
vafadarme@mums.ac.ir
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
Yes - There is 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 data after collection will be made available upon request for scientific purposes.
When the data will become available and for how long
After completion of the study
To whom data/document is available
Researchers
Under which criteria data/document could be used
for scientific purpose
From where data/document is obtainable
Vice research of Mashhad University of Medical Science
What processes are involved for a request to access data/document
Request from the Vice research of Mashhad University of Medical Science and if approved, send the documents to the applicant by the loyal doctor