Protocol summary

Summary
Loop diuretics and thiazides are mainstay of cardiac acute pulmonary edema treatment.these drugs lead to excretion of Mg in urine, that decreasing Mg in intra and extracellular fluids. in past trial reported depletion of Mg in intra and extracellular fluid by one month treatment of lasix or hydrochlorotiazid. and so Mg depletion leads to dysrhythmia, neuromuscular dysfunction, hypokalemia and hypocalcemia that resistance to treatment in CHF patient under treatment by diuresis. also MgSo4 infusion ( by depletion both catecholamine release and peripheral vascular resistance ) leads to both repletion and improving noncardiac pulmonary edema (in pheochromocytoma).It causes to improvement of respiratory failure and decreased intubation in severe asthma attack.in this trial,goal is whether that MgSo4 infusion in decreased hospitalization duration, decreased intubation, decreased dysrhythmia incidence that should be treat in ED, improvement both SaO2 and dyspnea score(verbal quantitative scale) in 6 hours after treatment initiation? this trial is doing randomized single blind clinical trial. pateints with acute cardiac pulmonary edema divided in 2 groups randomizely after that explained about trial and side effect of Mgso4 infusion. one group name is intervention that giving to patient 1 gr Mgso4 in 100 cc normal saline for 20 min, another group name is control that 100 cc normal saline infused for 20 min as placebo. both groups patients received Loop diuretics or thiazides in last month ago. if intervention patients show symptoms of Mgso4 toxicity (eg: patella areflexia or pulmonary depression) or with renal failure, exit this group. Primary outcome measure are MgSo4 infusion in decreased hospitalization duration, decreased intubation, decreased dysrhythmia incidence that should be treat in ED, improvement both SaO2 and dyspnea score(verbal quantitative scale) in 6 hours after treatment initiation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203089235N1
Registration date: 2012-10-16, 1391/07/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-16, 1391/07/25
Registrant information
Name
Seyyed Mahdi Zia Ziabari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1551 7531
Email address
sm-ziabari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
publicdomain
Expected recruitment start date
2012-06-05, 1391/03/16
Expected recruitment end date
2013-06-06, 1392/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of mgso4 infusion effect for treatment of patient with acute pulmonary edema arrived rasol and sina hospital from khordad 1391 to khordad 1392
Public title
Determination of mgso4 infusion effect for treatment of patient with acute pulmonary edema arrived rasol and sina hospital from khordad 1391 to khordad 1392
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patient with acute pulmonary edema Exclusion criteria:presence of mgso4 side effects
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university medical scince
Street address
Tehran porsina street north aspect of tehran university
City
Tehran
Postal code
1417613151
Approval date
2012-06-05, 1391/03/16
Ethics committee reference number
130/272/د/91

Health conditions studied

1

Description of health condition studied
Acute pulmonary edema
ICD-10 code
150.1
ICD-10 code description
with mention of heart disease NOS or heart failure

Primary outcomes

1

Description
hospitalization duration
Timepoint
for 6 hours after trial initation
Method of measurement
Compare of hospitalization duration in two groups

2

Description
dysrhythmia incidence that should be treat in ED
Timepoint
for 6 hours after trial initation
Method of measurement
Compare of demand to intubation in two groups

3

Description
necessary for intubation
Timepoint
for 6 hours after trial initation
Method of measurement
Compare of incidence of dysrhytmia that demand treatment in two groups

4

Description
improvement both SaO2 and dyspnea score(verbal quantitative scale) in 6 hours after treatment initiation
Timepoint
for 6 hours after trial initation
Method of measurement
Compare of Sao2 improvement more than 94% and dyspnea score (by verbal quantitative scale pathway) for 6 hours after treatment initiation in two groups

Secondary outcomes

1

Description
Decrease respiratory rate under 8/min
Timepoint
for 6 hours from tretment initation
Method of measurement
Account respiratory rate in 1 minute

2

Description
Diminish of deep tendon reflex
Timepoint
for 6 hours after treatment initation
Method of measurement
Monitoring of deep tendon reflex

Intervention groups

1

Description
In intervention group start treatment by o2 until o2Sat of patient >94% (minimum by 4 lit/min o2),plus Amp lasix 1 mgr/kg and Amp nitroglycerin 5 mic gr/min started and titrated 5 mic gr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure> 90 mmhg).these treatment are basic treatment of acute pulmonary edema. in addition to in intervention group gives 1 gr Mgso4 in 100 cc normal saline for 20 min.
Category
Treatment - Drugs

2

Description
In control group start treatment by o2 until o2Sat of patient >94% (minimum by 4 lit/min o2),Amp lasix 1 mgr/kg and Amp nitroglycerin by 5 mi cgr/min started and titrated 5 mi cgr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure> 90 mm hg).these treatment are basic treatment of acute pulmonary edema.but in control group we administrate basic treatment of acute pulmonary edema and not infused Mgso4. as we administrate 100 cc normal saline in 20 min for placebo instead Mgso4
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul and Sina hospital
Full name of responsible person
Seyyed Mahdi Zia Ziabari M.D
Street address
City
Rssht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university medical scince
Full name of responsible person
Dr. Akbar Fotohi
Street address
Teran Rasol hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university medical scince
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
Tehran university medical scince
Full name of responsible person
Dr.Seyyed Mahdi Zia Ziabari M.D
Position
Emergency medicine assistant
Other areas of specialty/work
Street address
Satarkhan shahrara rasoul hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
smzz592000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university medical scince
Full name of responsible person
Dr.Peyman Hafezi Moghadam
Position
Professor assistant of emergency medicine
Other areas of specialty/work
Street address
Satarkhan shahrara rasoul hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
hafezimoghadam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university medical scince
Full name of responsible person
Dr.Seyyed Mahdi Zia Ziabari M.D
Position
Emergency medicine assistant
Other areas of specialty/work
Street address
Tehran-shahrara-rasoul hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
smzz592000@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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