跳至主要内容
临床试验/CTRI/2013/10/004074
CTRI/2013/10/004074招募中不适用

A STUDY OF THE INCIDENCE OF ACUTE RENAL FAILUREIN VENOMOUS SNAKE BITE PATIENTS

Father Muller Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年2月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Incidence Of Acute Renal Failure in envenomed Patients

研究概览

简要总结

Snake bite is predominantly anoccupational hazard in the tropical countries; Agriculture remains theprincipal means of livelihood for 58.4% of India’s population and for aconsiderable proportion of the population in developing countries Henceexposing this group to the potential risk of snake bite. Acute renal failurecan occur with the bite of Any venomous snake and is more common with snakes ofthe viperine species. The worldwide published statistics on the incidence ofacute renal failure following venomous snake bite are inadequate as aproportion of the victims resorting to traditional means of therapy

Often resulting in deaths or chronicphysical handicap.

The Annual global mortality fromsnake bites is estimated at around 40000 Per year with around 10000 deathsoccurring per year in India alone(1).

The incidence of Acute renal failurein India is 13-32% following viper bite.(4)There is wide spread discrepancy with the data available on the Incidence ofAcute Renal Failure in snake bite patients with envenomation.

The venomous snakes belong to 4families Elapidiae, Viperidae, Hydrophiidea and Colubridea. Acute Renal failureis caused mainly by snakes of the Viperidae family (Russell Viper and Saw scaledViper) which are common species in India.

 Hence the study aims to determinethe Incidence Of Acute Renal Failure in patients of snake bite with signs ofenvenomation admitted to the hospital

STUDY DESIGN- is a descriptive study over a periodof one year in Father Muller Hospital.

A minimum of 30 patients with history of snake bite willbe studied over a period of one year

The following baseline investigations will be done

Hemoglobin, platelet counts, coagulation profileincluding clotting time using the twenty minute whole blood clotting test- 2mlof freshly drawn venous blood to be placed in a small glass vessel, it is to beleft undisturbed for twenty minutes at ambient temperature after the elapsedperiod the vessel is to be tipped once. If the blood is still liquid and runsout it indicates the presence of incoagulable blood which is a positive sign ofenvenomation. Bleeding time using the dukes method,  prothrombin time, partial thromboplastin timeand fibrin degradation products. Biochemical tests for blood urea, bloodcreatinine, serum electrolytes, liver function tests, blood sugars, urineroutine and microscopy, urine albumin

   Patientswill be evaluated for the related factors such as age, sex, concomitantdiseases, drug intake and prior documented renal disease.

  Coagulation parameters such asbleeding time, clotting time using the twenty minute whole blood clotting testwill be repeated sixth hourly. Blood urea, blood creatinine and urine outputwill 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 aserum creatinine of more than 4mg/dl at the time of admission with an acuterise of  more than 0.5 mg/dl, urineoutput less than 0.3ml/kg/hrx24 hrs, anuria lasting for more than 12hr and a GFR decrease of morethan 75% will be considered as patients who developed Acute Renal Failure. TheGFR will be calculated using the Cockroft Gault formula. Patients will befollowed up for a period of three days to detect the occurrence of renalfailure.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 1All patients with history of snake bite and with prior documented renal disease.
  • 2All patients less than 18 years of age.

结局指标

主要结局

Incidence Of Acute Renal Failure in envenomed Patients

时间窗: 1 year

次要结局

  • compare the trend with other centres(1 year)

研究者

发起方
Father Muller Medical College
申办方类型
Private medical college

研究点 (1)

Loading locations...

相似试验