Fluid responsiveness in renal transplant patients after tidal volume challenge test

Completed

• Conditions: End stage renal disease,

• Registration Number: CTRI/2022/04/042038
• Lead Sponsor: Mahatma Gandhi Hospital and Medical College

Brief Summary

Fluidadministration is the first line of treatment in patients with acutecirculatory failure. Dedicated algorithms and protocols of anaesthetic careregarding fluid therapy are key factors to prevent perioperative hypovolaemiaor hypervolaemia, which are both known to increase morbidity and length ofhospital stay. Fluidresponsiveness [i.e. the increase in stroke volume (SV) after a fluidchallenge] is limited to about 50% of critically ill or surgical patients. For this reason, fluid challengeadministration should be based on predictors of fluid responsiveness. Static indexes, such as central venouspressure and pulmonary wedge pressure, are unsuited for this purpose, but the dynamic indexes, such as pulsepressure variation (PPV) and stroke volume variation (SVV), reliably predictthe effect of fluid challenge administration during controlled mechanical ventilationwhen a tidal volume (VT) of at least 8 ml/kg is used.

Useof an intra-operative lung-protective ventilation strategy (VT of < 8 ml/kgpredicted body weight, PBW) is associated with a better outcome and is now suggested as standard practice inthe operating room. Such small VTslimit the assessment of fluid responsiveness in surgical patients by means ofdynamic indexes. To overcome this VT-related limitation of PPV and SVV, theprediction of fluid responsiveness can be achieved by applying functionalhaemodynamic tests aimed atincreasing venous return and enhancing right ventricle preload dependence. Among these, the interruption of positivepressure ventilation (the so-called end-expiratory occlusion test, EEOT), initially proposed in critically ill patients, has been tested in two studies of electivesurgical patients, with conflicting results. In patients ventilated with a meanVT of 8.2 ml/kg, the EEOT was unable to reliably predict fluid responsiveness, while the opposite was demonstrated inpatients ventilated with a mean VT of 6.8 ml/kg.

Myatraet al. recently proposed a new fluid responsiveness test called “the tidalvolume challengeâ€. They demonstratedthat an increase in the absolute value of PPV ≥3.5% induced by a transientincrease in tidal volume from 6 to 8 mL/kg for 1 minute could reliably predictthe increase in cardiac output in response to a fluid bolus performed at atidal volume of 6 mL/kg whereas the PPV value obtained at 6 mL/kg tidal volumewas unreliable for this purpose.Similar results were found for strokevolume variation (SVV) obtained from a contour analysis cardiac output monitor(threshold value: 2.5%). Thus, using atidal volume challenge might overcome the limitations of PPV as a predictiveindex of fluid responsiveness during low tidal volume ventilation.

RecentlyMessina A et al. also demonstrate thatthe changes in PPV and SVV obtained after Tidal Volume Challenge are reliableand comparable to the changes in CI and SVI obtained after EEOT performed at 8ml kg PBW in predicting fluid responsiveness in neurosurgical patients.

Wehypothesised that the baseline reliability of the dynamic indices in electivesurgical patients undergoing protective lung ventilation would be enhanced bythe use of functional haemodynamic tests. Therefore, we designed this study toassess the sensitivity and specificity of PPV and SVV changes after tidalvolume challenge in predicting fluid responsiveness in a renal transplantrecipient under general anaesthesia with lung protective ventilation

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Study Completion: 2022-01-11
• Last Update Posted: 2023-11-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients of end-stage renal disease undergoing renal transplantation -Age group of 18-60 years -Patient with written informed consent.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mahatma Gandhi Hospital and Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Hospital and Medical College

🇮🇳Jaipur, RAJASTHAN, India

Dr Ganesh Ramaji Nimje

Principal investigator

09503332784

ganesh.nimje8@gmail.com