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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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 hospital

STUDY 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.

 
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