CTRI Number |
CTRI/2022/04/042038 [Registered on: 21/04/2022] Trial Registered Prospectively |
Last Modified On: |
11/05/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
prospective observational study |
Study Design |
Single Arm Study |
Public Title of Study
|
Fluid responsiveness in renal transplant patients after tidal volume challenge test |
Scientific Title of Study
|
Assessment of Fluid Responsiveness after Tidal Volume Challenge in Renal Transplant Recipients: A Prospective Observational Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ganesh Ramaji Nimje |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Hospital and Medical College, Jaipur |
Address |
Professor Quarter Type IIA 004
Mahatma Gandhi Hospital and Medical College Sitapura Jaipur
Jaipur RAJASTHAN 302022 India |
Phone |
9503332784 |
Fax |
|
Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ganesh Ramaji Nimje |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Hospital and Medical College, Jaipur |
Address |
Professor Quarter Type IIA 004
Mahatma Gandhi Hospital and Medical College Sitapura Jaipur
Jaipur RAJASTHAN 302022 India |
Phone |
9503332784 |
Fax |
|
Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ganesh Ramaji Nimje |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Hospital and Medical College, Jaipur |
Address |
Professor Quarter Type IIA 004
Mahatma Gandhi Hospital and Medical College Sitapura Jaipur
Jaipur RAJASTHAN 302022 India |
Phone |
9503332784 |
Fax |
|
Email |
ganesh.nimje8@gmail.com |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Hospital and Medical College |
|
Primary Sponsor
|
Name |
Mahatma Gandhi Hospital and Medical College |
Address |
Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan |
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 Ganesh Ramaji Nimje |
Mahatma Gandhi Hospital and Medical College |
Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan Jaipur RAJASTHAN |
09503332784
ganesh.nimje8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
-Patients of end-stage renal disease undergoing renal transplantation
-Age group of 18-60 years
-Patient with written informed consent
|
|
ExclusionCriteria |
Details |
-Patient refusal
-Cadaveric donor renal transplantation
-Recurrent cardiac arrhythmia
-Reduced ventricular systolic function - left (ejection fraction <40%)
-BMI more than 30
-Intra-operative use of vasopressors or inotropes before or during VTC
-Chronic lung disease
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine efficacy of PPV and SVV changes after tidal volume challenge in predicting fluid responsiveness in a renal transplant recipient under general anaesthesia with lung protective ventilation. |
The tidal volume Challenge (TVC) test will be performed when patient develop hypotension (fall in Systolic Arterial Pressure 20 % from the baseline / MAP below 70 mm/Hg) prior to administration of fluid bolus or any vasopressor agents. Only the data obtained from the first fluid challenge administered to each enrolled patient will be used for the analysis. |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2022 |
Date of Study Completion (India) |
01/11/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Fluid
administration is the first line of treatment in patients with acute
circulatory failure. Dedicated algorithms and protocols of anaesthetic care
regarding fluid therapy are key factors to prevent perioperative hypovolaemia
or hypervolaemia, which are both known to increase morbidity and length of
hospital stay. Fluid
responsiveness [i.e. the increase in stroke volume (SV) after a fluid
challenge] is limited to about 50% of critically ill or surgical patients. For this reason, fluid challenge
administration should be based on predictors of fluid responsiveness. Static indexes, such as central venous
pressure and pulmonary wedge pressure, are unsuited for this purpose, but the dynamic indexes, such as pulse
pressure variation (PPV) and stroke volume variation (SVV), reliably predict
the effect of fluid challenge administration during controlled mechanical ventilation
when a tidal volume (VT) of at least 8 ml/kg is used.
Use
of an intra-operative lung-protective ventilation strategy (VT of < 8 ml/kg
predicted body weight, PBW) is associated with a better outcome and is now suggested as standard practice in
the operating room. Such small VTs
limit the assessment of fluid responsiveness in surgical patients by means of
dynamic indexes. To overcome this VT-related limitation of PPV and SVV, the
prediction of fluid responsiveness can be achieved by applying functional
haemodynamic tests aimed at
increasing venous return and enhancing right ventricle preload dependence. Among these, the interruption of positive
pressure ventilation (the so-called end-expiratory occlusion test, EEOT), initially proposed in critically ill patients, has been tested in two studies of elective
surgical patients, with conflicting results. In patients ventilated with a mean
VT of 8.2 ml/kg, the EEOT was unable to reliably predict fluid responsiveness, while the opposite was demonstrated in
patients ventilated with a mean VT of 6.8 ml/kg.
Myatra
et al. recently proposed a new fluid responsiveness test called “the tidal
volume challengeâ€. They demonstrated
that an increase in the absolute value of PPV ≥3.5% induced by a transient
increase in tidal volume from 6 to 8 mL/kg for 1 minute could reliably predict
the increase in cardiac output in response to a fluid bolus performed at a
tidal volume of 6 mL/kg whereas the PPV value obtained at 6 mL/kg tidal volume
was unreliable for this purpose. Similar results were found for stroke
volume variation (SVV) obtained from a contour analysis cardiac output monitor
(threshold value: 2.5%). Thus, using a
tidal volume challenge might overcome the limitations of PPV as a predictive
index of fluid responsiveness during low tidal volume ventilation.
Recently
Messina A et al. also demonstrate that
the changes in PPV and SVV obtained after Tidal Volume Challenge are reliable
and comparable to the changes in CI and SVI obtained after EEOT performed at 8
ml kg PBW in predicting fluid responsiveness in neurosurgical patients.
We
hypothesised that the baseline reliability of the dynamic indices in elective
surgical patients undergoing protective lung ventilation would be enhanced by
the use of functional haemodynamic tests. Therefore, we designed this study to
assess the sensitivity and specificity of PPV and SVV changes after tidal
volume challenge in predicting fluid responsiveness in a renal transplant
recipient under general anaesthesia with lung protective ventilation |