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CTRI Number  CTRI/2016/07/007111 [Registered on: 21/07/2016] Trial Registered Prospectively
Last Modified On: 13/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare different fluid therapy approach in renal transplant recipient during transplantation 
Scientific Title of Study   Comparison of Different Rates of Intraoperative Fluid Therapy on Early Graft Function during Live Related Renal Transplantation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek singh 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  AB8 AIIMS,ANSARI NAGAR EAST
AIIMS,ANSARI NAGAR EAST
South
DELHI
110029
India 
Phone  8287652624  
Fax    
Email  bikunrs77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Ramachandran 
Designation  Additional Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  AB8 AIIMS,ANSARI NAGAR EAST

South
DELHI
110029
India 
Phone  9868397812  
Fax    
Email  rashmiramachandran1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abhishek singh 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  AB8 AIIMS,ANSARI NAGAR EAST
AIIMS,ANSARI NAGAR EAST
South
DELHI
110029
India 
Phone  8287652624  
Fax    
Email  bikunrs77@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  AIIMS,ANSARI NAGAR EAST,110029 
Type of Sponsor  Research institution and hospital 
 
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 Abhishek singh  AIIMS  AB8,MAIN OT COMPLEX, DEPARTMENT OF ANESTHESIOLOGY ,PAIN MEDICINE AND CRITICAL CARE, AIIMS,ANSARI NAGAR EAST
South
DELHI 
8287652624

bikunrs77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ,AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic kidney disease stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard fluid therapy   Patient will receive intra venous fluid [Balanced salt solution] according to following protocol- Fasting deficit- 2ml/kg/hr of duration of fasting up to a maximum of 10 hours. Fifty percent of this deficit will be replaced in the first hour of surgery, 25% each in the next two hours. Maintenance fluid- will be calculated according to Holliday and Segar’s formula (4-2-1 rule) and replaced each hour. Blood loss- any blood loss occurring below the allowable blood loss will be replaced with crystalloids and if the blood loss exceeds allowable blood loss it will be replaced with cross matched blood. At the start of vascular anastomosis , CVP will be targeted to 15 mm of Hg. Extra fluid will be given if required to achieve target CVP till declamping of vessels.  
Intervention  Targeted therapy group  Patients will receive intra venous fluid at rate of 1ml/kg/hr from start of surgery till start of vascular anastomosis. Any blood loss occurring below the allowable blood loss will be replaced with crystalloids and if the blood loss exceeds allowable blood loss it will be replaced with cross matched blood. At the start of anastomosis intra venous fluid will be given to achieve CVP of 15 mm of Hg. The CVP will be maintained at this value till declamping of renal vessels. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing live related renal transplantation.
Donor graft is procured by laparoscopic nephrectomy
 
 
ExclusionCriteria 
Details  Severe left ventricular dysfunction

Cardiomyopathy with ejection fraction less than 40%.
Diabetics

Post dialysis hemoglobin less than 8 gm %

Severe pulmonary disease and liver disease

Refusal to participate in the study

Vascular anomaly of donated organ

Intraoperative transfusion of blood
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Serum creatinine level on postoperative day 1 in patients receiving fluid according to two different fluid regimens  Serum creatinine level on postoperative day 1 in patients receiving fluid according to two different fluid regimens 
 
Secondary Outcome  
Outcome  TimePoints 
Fall in serum creatinine ,blood urea and serum electrolytes as compared to Preoperative level  patient followed till post op day 6 
Onset of urine production in graft after declamping of vessels  immediately after declamping of renal artery 
4 hour urine output after declamping of vessels  4 hours following declamping 
24 hour urine output  post op day 1 
Need for postoperative hemodialysis   till post op day 6 
Any signs of fluid overload  till post of day 6 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2016 
Date of Study Completion (India) 30/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Renal transplantation is now being recognized as treatment of choice for patients of end stage renal disease. Several studies in the previous decades have shown that the hemodynamic status of the patient during transplantation have effect on graft function . Early graft function is crucial for successful kidney transplantation. Many factors affect graft function. Some of them are donor age, donor hypertension, prolonged anastomosis time, preoperative dialysis with too much ul­trafiltration causing volume contraction in the recipient and pelvic atherosclerosis . Prolonged cold ischemia time and warm ischemia time also have significant effect on graft function. Among all the factors affecting graft outcome, recipient hydration status at time of de-clamping of the vessels after graft anastomosis is also an important factor for the development of delayed graft function. For proper functioning of graft in early post-operative period, it is necessary that graft is adequately perfused at the time of operation.

Patient with chronic renal failure have narrow margin of safety with intravenous hydration and may oscillate between hypovolemia and hypervolemia . Fluid given too fast may theoretically lead to cardiac decompensation and signs of fluid overload in patients with poor cardiac function while on the other hand fluid restriction may lead to hypotension and acidosis in patients with chronic renal failure . Thus intravascular volume and arterial blood pressure needs to be carefully adjusted for effective perfusion of graft as well as to avoid over hydrating the patient. Traditionally fluid replacements for patients undergoing surgery is done according to volume deficit due to overnight fasting, maintenance fluid therapy according to Segar’s formula, intraoperative losses and third space losses . Fluid given according to above calculation may be redistributed by the time of declamping of vessels leading to inadequate graft perfusion. This study, thus has been planned to compare the different fluid hydration regimens, traditional fluid replacement method and targeted fluid replacement before declamping of renal vessels, on early graft function during live related renal transplantation. This study will also evaluate if different regimens will have any hemodynamic or metabolic side effects.

 


 
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