| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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)?
|
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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 ulÂtrafiltration 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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