Our aim of this investigation is new proposed protocol for treatment rice tablet and phosphide compounds toxicity by using new ways is more effective than others. This protocol is going to do on patients coming to Imam Khomaini hospital and this prognosis compare with previous prognosis at a past year.
All patients coming to Imam Khomaini toxicity center and having history of consumption rice tablet or phosphide compounds will be lavaged with potassium permanganate solution and then gavaged with sharchol, mixture of coconut oil and sodium bicarbonate. Patients transport to ICU and monitor then treatment with Hydrocortison Amp., magnesium sulfate, sodium bicarbonate, NAC and Ranitidine Amp.
In this clinical trial carried out on 66 patients with phosphid compounds toxicity and new protocol prognosis compares with old protocol (on 66 patients at last year).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072318571N1
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Reza Hedayat Yaghoobi
Name of organization / entity
Kermanshah University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6332
Email address
r.hyaghoobi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of prognosis of patients with rice tablet poisoning (phosphide) the new and old protocol
Public title
Study of prognosis of patients with rice tablet toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Consumed aluminum phosphide compounds and the symptoms of poisoning including: retro sternal pain; hypotention and metabolic acidosis.
Exclusion criteria:Dead patients; history of other drugs toxicity; admission after 24h of concumption.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science
Street address
Shahid Beheshti.Blv, Kermanshah
City
Kermanshah
Postal code
Approval date
2014-02-04, 1392/11/15
Ethics committee reference number
49398
Health conditions studied
1
Description of health condition studied
poisining
ICD-10 code
T60.8
ICD-10 code description
Organophosphate and carbamate insecticides
Primary outcomes
1
Description
Renal complications
Timepoint
Day
Method of measurement
watch
2
Description
Liver complications
Timepoint
Day
Method of measurement
watch
3
Description
cardiovascular complications
Timepoint
day
Method of measurement
watch
4
Description
Survival rate
Timepoint
From coming to hospital to cure or expire
Method of measurement
watch
5
Description
duration of admission in ICU and ward
Timepoint
Hour
Method of measurement
watch
Secondary outcomes
1
Description
Organ damage
Timepoint
day
Method of measurement
day
2
Description
Organ damage
Timepoint
day to day
Method of measurement
daily
Intervention groups
1
Description
Gasteric lavage with potassium permanganate solution1/10000 and then gavaged with 100g sharchol and mixture of 100cc coconut oil and 50cc sodium bicarbonate and sorbitol. Patients transport to ICU and monitor then treatment with 100mg Hydrocortison Amp. QID or dexametazone 8mg TDS(IV), 3g magnesium sulfate IV stat then 6g BD during 3-5 days (contraindicated in HTN), 50meq sodium bicarbonate in serum TDS (contraindicated in NaHCO3>24-30, NAC with acetaminophene antidote dose(contraindicated in asthma) and 50mg Ranitidine Amp. TDS.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomaini hospital
Full name of responsible person
Reza Hedayat Yaghoobi
Street address
Emam Reza Hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Kermanshah University Of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti Blv, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Kermanshah 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
Kermanshah University of Medical Science
Full name of responsible person
Reza Hedayat Yaghoobi
Position
Resident of internal medicine
Other areas of specialty/work
Street address
University of Medical Science
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
R.Hyaghoobi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Seyed Jafar Navvabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomaini hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3728 5054
Fax
Email
JNAVABI2000@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Reza Hedayat Yaghoobi
Position
Resident of internal medicine
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)