Validation of Cardiometry in Resuscitation of Patients Undergoing Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Validation of Electrical Cardiometry in Resuscitation of Patients Undergoing Orthotopic Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228329
• Other study ID #: N-43-2017
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: December 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

aim of our study to validate electrical cardiometry readings against same readings by transoesophageal echo. we will validate stroke volume (SV) readings stroke volume variation(SVV), index of contractility.

Description:

Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between 1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG, peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature, end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A 7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted into the right internal jugular vein.

All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl). Norepinephrine will be administered if the mean arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2 despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2

Electrical cardiometry (EC) Examination:

1. ECG electrodes will be placed on the bare skin of patients in the following positions:

1. On the left neck below the ear;

2. Directly above the midpoint of the left clavicle;

3. Along the left mid-axillary line at the level of the xiphoid process;

4. Two inches caudal from the third electrode.

2. Patient characteristics of sex, age, height and weight will be entered into the monitor.

3. Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to data collection.

4. The EC monitor will be programmed to capture moving averages of variables based on the previous 10 cardiac cycles and to record those averages every10 s.

5. Only EC data with a signal quality index (SQI) of >70 will be included in the analysis.

Echo Examination:

1. A single LVOT diameter will be measured for each patient as the distance between the inflection points at the base of the aortic valve cusps from the left ventricle long axis view during systole.

2. Assuming a circular cross section, the LVOT area will be calculated from the LVOT diameter as:

π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785

3. Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately proximal to the aortic valve in 5 chamber deep transgastric view.

4. The sonographer manually will trace the velocity-time envelope.

5. SV values will be identified for 10 cycles and averaged to obtain SV-Doppler max and SV-Doppler min. The mean SV (SV-Doppler mean) will be calculated as (SV-Doppler max - SV-Doppler min)/2.

6. SVV-Doppler will be calculated as (SV-Doppler max - SV-Doppler min)/SV-Doppler mean.

7. Peak aortic velocity, time to peak and mean acceleration will be calculated.

Mini Fluid challenge:

1. Mini fluid challenge will be done by 150 cc crystalloid over 1 min

2. 2 sets of measurement of SV and SVV will be obtained

1. The first set of measurement will be obtained before fluid challenge.

2. The second set will be obtained immediately after fluid challenge. Other data will be recorded as;heart rate (HR), systolic BP, Diastolic BP, mean BP, CVP and pulse pressure variation (PPV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA II to IV patients with end-stage liver disease

• patients undergoing orthotopic living donor liver transplantation

• age > 18 years

Exclusion Criteria:

• acute fulminant liver failure

• age < 18 years

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Other:
• fluid boluses
fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital , Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. Review. German. — View Citation

Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. Review. — View Citation

Rossi G, Langer M, Maggi U, Reggiani P, Caccamo L, Gatti S, Paone G, Vannelli A, Prato P, Doglia M, Melada E, Latham L, Fassati LR. Veno-venous bypass versus no bypass in orthotopic liver transplantation: hemodynamic, metabolic, and renal data. Transplant Proc. 1998 Aug;30(5):1871-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke volume	record stroke volume assessed by noninvasive cardiometry and TEE	5 minutes after reperfusion.
Primary	stroke volume	record stroke volume assessed by noninvasive cardiometry and TEE	15 minutes after dissection phase.
Secondary	stroke volume variation	record stroke volume assessed by noninvasive cardiometry and TEE	5 minutes after reperfusion.
Secondary	stroke volume variation	record stroke volume variation assessed by noninvasive cardiometry and TEE	15 minutes after dissection phase