Fluid responsiveness in liver transplant patients after tidal volume challenge test

Completed

• Conditions: Chronic hepatic failure,

• Registration Number: CTRI/2022/04/042099
• Lead Sponsor: Mahatma Gandhi Hospital and Medical College

Brief Summary

•     Fluidadministration is the first line of treatment in patients with acutecirculatory failure.

•     Fluid responsiveness[i.e. the increase in stroke volume (SV) after a fluid challenge] is limited toabout 50% of critically ill or surgical patients.

•     Static indexes, such ascentral venous pressure and pulmonary wedge pressure, are unsuited for thispurpose

•     But the dynamic indexes,such as pulse pressure variation (PPV) and stroke volume variation (SVV),reliably predict the effect of fluid challenge administration during controlledmechanical ventilation when a tidal volume (VT) of at least 8 ml/kg is used.

•     Use of an intra-operativelung-protective ventilation strategy (VT of < 8 ml/kg predicted body weight,PBW) is now suggested as standard practice in the operating room.

•     Such small VTs limit theassessment of fluid responsiveness in surgical patients by means of dynamicindexes.

•     To overcome this **Myatraet al**. recently proposed a new fluid responsiveness test called “the tidalvolume challengeâ€.

•     They demonstrated that anincrease in the absolute value of PPV ≥3.5% induced by a transient increase intidal volume from 6 to 8 mL/kg for 1 minute could reliably predict the increasein cardiac output in response to a fluid bolus performed at a tidal volume of 6mL/kg whereas the PPV value obtained at 6 mL/kg tidal volume was unreliable forthis purpose.

•     Similar results werefound for stroke volume variation (SVV) -threshold value: 2.5%

•     Thus, using a tidalvolume challenge might overcome the limitations of PPV as a predictive index offluid responsiveness during low tidal volume ventilation.

•     Recently **Messina A etal.**also demonstrate thatthe

•     changes in PPV and SVV obtainedafter the Tidal Volume Challenge are reliable and comparable to the changes in CIand SVI obtained after EEOT performed at 8 ml kg PBW in predicting fluidresponsiveness in neurosurgical patients.

Therefore,we designed this study to assess the sensitivity and specificity of PPV and SVVchanges after tidal volume challenge in predicting fluid responsiveness in aliver transplant recipient under general anaesthesia with lung-protective ventilation

**Methodology**

•     Afterapproval of the study by the institutional ethical committee & obtaining writteninformed consent patients posted for liver transplant surgery will be includedin the study.

•     In all patients standardintra-operative monitoring, including heart rate, peripheral oxygen saturation,continuous electrocardiography, and non-invasive blood pressure monitoring willbe attached

•     Induction agents:Fentanyl 2 mcg/kg, Propofol 1-2 mg/kg, cisatracurium besilate 0.15 to 0.2 mg/kg

•     Maintaince Agents: O2+Air+ Isoflurane+ Intermittent cisatracurium

•     Ventilatory Setting:Mode- Volume control, Tidal Volume- 6 ml/kg PBW, PEEP- 5, ETCO2- 30-40,SpO2>96

•     PBW (kg) was calculatedas follows: X + 0.91[height (cm) - 152.4]; (X = 50 for men and 45.5 for women)

•     After Induction: 7.5Fr triple lumen line inserted in the right internal jugular vein & invasiveblood pressure monitoring will be obtained by inserting a 20-G cannula into theradial artery.

•     Hemodynamic monitoring is done by attaching the FlowTrac system to the patient

•     These are routinely doneprocedures during liver transplants.

•     Baseline hemodynamicparameters like Pulse Rate (PR), Mean arterial blood pressure(MAP), CentralVenous Pressure(CVP),Stroke Volume(SV), Stroke Volume Index (SVI), CardiacIndex(CI), Stroke Volume Variation(SVV), Pulse Pressure Variation(PPP) will berecorded.

Thetidal volume Challenge (VTC) test will be performed when the patientdevelops hypotension (fall in Systolic Arterial Pressure > 20 % from thebaseline / MAP below 65 mm/Hg) prior to administration of fluid bolus or anyvasopressor agents. Before tidal volume challenge hemodynamic parameters likePulse Rate (PR), Mean arterial blood pressure (MAP), Central VenousPressure(CVP), Stroke Volume(SV), Stroke Volume Index (SVI), Cardiac Index(CI),Stroke Volume Variation(SVV), Pulse Pressure Variation(PPP) will be recorded.The “tidal volume challenge†will be performed by transiently increasing tidal volume (VT) (from 6 up to 8 mL/kg PBW for 1 minute), and another set ofhemodynamic measurements including the PPV (PPV8) and SVV (SVV8) will berecorded after 1 minute. Additionally, the changes in the value of PPV and SVV(ΔPPV6 − 8 = PPV8 – PPV6 and ΔSVV6 − 8 = SVV8 – SVV6) will be calculated. Thetidal volume will be reduced back to 6 ml/kg PBW with the completion of TVC andhemodynamic parameter will be recorded.After that fluid challenge(FC) will be achieved by infusing 250 ml of plasmalytesolution over a period of 10 mins and set of hemodynamic measurements will berecorded. Patients will be classified as a responder if there is an increase inStroke Volume Index (SVI) by more than 10 % after fluid challenge.  Only the hemodynamic data obtained from thefirst fluid challenge administered to each enrolled patient will be used forthe analysis. For the safety of the patient, the interruption of the protocolwill be at the discretion of the attending anaesthetist.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Study Completion: 2023-05-22
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients with chronic liver disease undergoing liver transplantation -Age group of 18-60 years -Patient with written informed consent.

Exclusion Criteria

• Patient refusal -Cadaveric donor liver 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 liver transplant recipient under general anaesthesia with lung protective ventilation.	Time point- After induction of anaesthesia, the tidal volume Challenge (VTC) test will be performed when patient develop hypotension (fall in Systolic Arterial Pressure 20 % from the baseline / MAP below 65 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

9503332784

ganesh.nimje8@gmail.com