| CTRI Number |
CTRI/2013/10/004074 [Registered on: 18/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
The occurrence of kidney failure following poisonous snake bite. |
|
Scientific Title of Study
|
A STUDY OF THE INCIDENCE OF ACUTE RENAL FAILURE
IN VENOMOUS SNAKE BITE PATIENTS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muhamed Qamar Ali |
| Designation |
PG Resident Medicine |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Dr Muhamed Qamar Ali
Department Of Medicine
Father Muller Medical College
Mangalore Asif Asrar Villa
V P Nagar
2 Cross
Udupi
Karnataka Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8050485284 |
| Fax |
|
| Email |
muhammadali86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Sundara bhat |
| Designation |
Professor in Medicine |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Dr K Sundara bhat
Department Of Medicine
Father Muller Medical College
Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9845099492 |
| Fax |
|
| Email |
drksbhat@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Muhamed Qamar Ali |
| Designation |
PG Resident Medicine |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Dr Muhamed Qamar Ali
Department Of Medicine
Father Muller Medical College
Mangalore Asif Asrar Villa
V P Nagar
2 Cross
Udupi
Karnataka
KARNATAKA 575002 India |
| Phone |
8050485284 |
| Fax |
|
| Email |
muhammadali86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Department Of Medicine
Father Muller Medical College
Mangalore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muhamed Qamar Ali |
MICU,GENERAL WARDS,FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
Father Muller Medical College And Hospital
Kankanady
Mangalore 575002
Dakshina Kannada Dakshina Kannada KARNATAKA |
8050485284
muhammadali86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
envenomed snake bite patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 patients with history of snake bite and presenting with signs of systemic envenomation.
2 patients with history of unknown bite but presenting with signs of systemic envenomation
|
|
| ExclusionCriteria |
| Details |
1 All patients with history of snake bite and with prior documented renal disease.
2 All patients less than 18 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence Of Acute Renal Failure in envenomed Patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the trend with other centres |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Snake bite is predominantly an
occupational hazard in the tropical countries; Agriculture remains the
principal means of livelihood for 58.4% of India’s population and for a
considerable proportion of the population in developing countries Hence
exposing this group to the potential risk of snake bite. Acute renal failure
can occur with the bite of Any venomous snake and is more common with snakes of
the viperine species. The worldwide published statistics on the incidence of
acute renal failure following venomous snake bite are inadequate as a
proportion of the victims resorting to traditional means of therapy
Often resulting in deaths or chronic
physical handicap.
The Annual global mortality from
snake bites is estimated at around 40000 Per year with around 10000 deaths
occurring per year in India alone (1).
The incidence of Acute renal failure
in India is 13-32% following viper bite. (4)
There is wide spread discrepancy with the data available on the Incidence of
Acute Renal Failure in snake bite patients with envenomation.
The venomous snakes belong to 4
families Elapidiae, Viperidae, Hydrophiidea and Colubridea. Acute Renal failure
is caused mainly by snakes of the Viperidae family (Russell Viper and Saw scaled
Viper) which are common species in India.
Hence the study aims to determine
the Incidence Of Acute Renal Failure in patients of snake bite with signs of
envenomation admitted to the hospitalSTUDY DESIGN- is a descriptive study over a period
of one year in Father Muller Hospital.
A minimum of 30 patients with history of snake bite will
be studied over a period of one year
The following baseline investigations will be done
Hemoglobin, platelet counts, coagulation profile
including clotting time using the twenty minute whole blood clotting test- 2ml
of freshly drawn venous blood to be placed in a small glass vessel, it is to be
left undisturbed for twenty minutes at ambient temperature after the elapsed
period the vessel is to be tipped once. If the blood is still liquid and runs
out it indicates the presence of incoagulable blood which is a positive sign of
envenomation. Bleeding time using the dukes method, prothrombin time, partial thromboplastin time
and fibrin degradation products. Biochemical tests for blood urea, blood
creatinine, serum electrolytes, liver function tests, blood sugars, urine
routine and microscopy, urine albumin
Patients
will be evaluated for the related factors such as age, sex, concomitant
diseases, drug intake and prior documented renal disease.
Coagulation parameters such as
bleeding time, clotting time using the twenty minute whole blood clotting test
will be repeated sixth hourly. Blood urea, blood creatinine and urine output
will be monitored daily to detect Acute renal failure using the RIFLE criteria.
Patients with a 3 fold rise of serum creatinine over the baseline value or a
serum creatinine of more than 4mg/dl at the time of admission with an acute
rise of more than 0.5 mg/dl, urine
output less than 0.3ml/kg/hrx24 hrs, anuria lasting for more than 12hr and a GFR decrease of more
than 75% will be considered as patients who developed Acute Renal Failure. The
GFR will be calculated using the Cockroft Gault formula. Patients will be
followed up for a period of three days to detect the occurrence of renal
failure.
|