Protocol summary

Summary
The aim of the present study is to assess the effectiveness of repeated cyclosphosphamide (CP) and methylprednisolone (MP) combination in the treatment of paraquat (PQ) poisoning in a double-blind, randomized clinical trial. Eligible participants in this study are patients with moderate to severe PQ poisoning within 24 hours of hospitalization. Due to the unavailability of equipment to measure serum PQ levels, moderate to severe PQ poisoning is confirmed if urine samples turn dark blue in the urinary sodium dithionite test. Patients will be allocated in a random fashion between case and control groups. The sample size is calculated based on previous studies almost 46 patients. Taking any other poisons, underlying renal, hepatic, and pulmonary diseases, and unconsciousness are considered as exclusion criteria. All patients receive two cycles of eight hours hemoperfusion with charcoal, and undergo emergency hemodialysis in the fastest time possible. After the dialysis, the intervention group receive 15 mg/Kg CP for two days and 1g MP for three days. Each drug infuses in 200 cc dextrose saline 5 % during two hours. The control group receives routine, supportive care and 200 cc dextrose saline 5% infusion during two hours for three days as placebo. At the time of admission, demographic characteristics, history of underlying diseases, and time between PQ intake and the entrance to the emergency department are recorded. During the study daily measurement of liver function test, renal function test and blood gas are performed. Finally mentioned paraclinic findings and mortality between the two group are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012611873N2
Registration date: 2014-03-17, 1392/12/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Amir Mandegar
Name of organization / entity
Ahvaz Jundishapur University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 9539
Email address
mandegar.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz JondyShapor University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pulse therapy with glucocorticoids and cyclophosphamide in patients with paraquat poisoning
Public title
Efficacy of glucocorticoids and cyclophosphamide in the treatment of paraquat poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: approved the pesticide paraquat during the last 24; moderate to severe poisoning with this herbicide The exclusion criteria: In addition to any other pesticide paraquat; the underlying liver disease - kidney - lung; The incidence of treatment-related complications during interventional treatment
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jondishapour University of Medical Sciences
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
u-91112

Health conditions studied

1

Description of health condition studied
poisoning with the pesticide paraquat
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Kidney failure
Timepoint
Daily during treatment
Method of measurement
BUN & Cr..Cr: 1.4 mg/dl (i.e., mean normal value + 2 standard deviations).

2

Description
Mortality
Timepoint
Constantly during treatment
Method of measurement
Observation

3

Description
Hepatitis (liver failure)
Timepoint
Daily during treatment
Method of measurement
(ST) and(ALT) values were > 70 U/L (normal valueis < 35 U/L) or when total bilirubin was > 3.0 mg/dl (normal valueis < 1.4 mg/dl).

4

Description
hypoxia
Timepoint
Daily during treatment
Method of measurement
PaO2 < 80 mm Hg at roomair.

Secondary outcomes

empty

Intervention groups

1

Description
ent emergency hemodialysis in the fastest time possible. After the dialysis, the intervention group received 15 mg/Kg CP for two days and 1g MP for three days. Each drug infused in 200 cc dextrose saline 5 % during two hours.
Category
Treatment - Drugs

2

Description
After the initial measures, including gastric lavage and administration of activated charcoal and two charcoal dialysis. The control group consisted of normal saline placebo is used, 200 cc given intravenously over two hours to three days is prescribed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Ahmsd Ghorbani
Street address
Razi Hospital, Palestine St.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz JondyShapour University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Vice chancellor for research,Ahvaz JondyShapour University of Medical Sciences, Ahvaz, golestan Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz JondyShapour 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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr Ahmad Ghorbani
Position
Forensic and clinical toxicologist
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1333 5935
Fax
Email
ahmadghorbanidr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr Amir Mandegar
Position
Internist
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3030
Fax
Email
mandegaramir@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Amir Mandgar
Position
Internist
Other areas of specialty/work
Street address
Esfand St., Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 1374 3030
Fax
Email
mandegaramir@gmail.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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