Protocol summary

Summary
This study is designed to investigate the effect of gastric gavage of intralipid serum in the acute poisoning of aluminum phosphate (AlP) due to high mortality of this rodenticide and the fact that the most important step in the management of this toxicity is reducing the absorption of phosphine gas in the gastrointestinal tract. In this study, the patients with acute ingestion of AlP (less than 1 hour) would be included and randomized in to 2 groups. In the control group, the routine steps in the gastric lavage with potassium permanganate would be done. In the case group, 500cc of intralipid serum (10%) would be administered via gastric gavage. The clinical manifestations, hemodynamic changes, acid-base disorders and the mortality rate would be compared between case and control group via appropriate statistical tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205279883N1
Registration date: 2012-12-09, 1391/09/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Forough Sadat Sayyah Melli
Name of organization / entity
Department of Forensic Medicine and Toxicology
Country
Iran (Islamic Republic of)
Phone
+98 21 7758 2816
Email address
f-sayyah@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intralipid serum gavage on the mortality of acute poisoning of aluminum phosphate
Public title
The effect of intragastric administration of intralipid serum on the mortality of acute poisoning of aluminum phosphate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Acute poisoning of aluminum phosphate with the ingestion time of less than 1 hour.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
PourSina St.
City
Tehran
Postal code
Approval date
2011-11-28, 1390/09/07
Ethics committee reference number
90/D/130/1596

Health conditions studied

1

Description of health condition studied
Aluminium phosphate poisoning
ICD-10 code
T47.1
ICD-10 code description
Poisoning: Other antacids and anti-gastric-secretion drugs

Primary outcomes

1

Description
Mortality rate
Timepoint
after intervention
Method of measurement
Evaluation of clinical manifestation (BP, HR, RR, Pupil size), hemodynamic changes, acid-base disorders

Secondary outcomes

empty

Intervention groups

1

Description
Control Group: Routine gastric decontamination with potassium permanganate.
Category
Treatment - Drugs

2

Description
Intervention group: Gastric lavage with 500cc of intralipid serum (10%)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr Forough Sadat Sayyah Meli
Street address
Kamali St.,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sayyah Meli
Street address
PourSina St,
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 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
Department of Forensic Medicine and Toxicology, Tehran University of Medical Scinences
Full name of responsible person
Dr Forough Sadat Sayyah Meli
Position
Resident
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 914 116 3143
Fax
Email
f-sayyah@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Forensic Medicine and Toxicologyو Tehran University of Medical Scinences
Full name of responsible person
Dr Forough Sadat Sayyah Meli
Position
Resident
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 914 116 3143
Fax
Email
f-sayyah@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Forensic Medicine and Toxicology, Tehran University of Medical Scinences
Full name of responsible person
Dr Forough Sadat Sayyah Meli
Position
Resident
Other areas of specialty/work
Street address
PourSina St.,
City
Tehran
Postal code
Phone
+98 914 116 3143
Fax
Email
f-sayyah@razi.tums.ac.ir
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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