The Validity of Central Venous to Arterial Co2 Difference During Living Donor Liver Transplantation

NCT ID: NCT03123172

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2017-07-15

Brief Summary

Study will be conducted on 20 patients ASA III-IV undergoing orthotopic liver transplantation. Blood samples will be obtained simultaneously from arterial line, pulmonary artery catheter and central venous catheter at 4 specific time points baseline, immediately after insertion of PAC; at the end of the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping. Blood samples will be also obtained whenever PPV is more than 15% and patient will need fluid therapy

Detailed Description

The study will include 20 ASA II to IV patients with end-stage liver disease, scheduled for orthotropic liver transplantation between. 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 kPa and 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. A pulmonary artery catheter (OPTIQ SVO2 ⁄CCO; Abbott Laboratories, North Chicago, IL, USA) will also be inserted into the right internal jugular vein. The pulmonary artery catheter (PAC) will be positioned using wedge pressure and confirmed with fluoroscopy.

All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If PPV is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of or albumin 5% to maintain PPV ≤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 if systemic vascular resistance was less than 600 dyne/sec/cm5 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 Blood samples will be obtained simultaneously from arterial line, pulmonary artery catheter and central venous catheter at 4 specific time points baseline, immediately after insertion of PAC; at the end of the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping. Blood samples will be also obtained whenever PPV is more than 15% and patient will need fluid therapy. Central venous oxygen saturation (ScVO2) will be recorded. Pcv-a CO2 gap will be calculated from a sample taken from the central venous catheter, the tip of which was confirmed to be in the superior vena cava near or at the right atrium by radiography. Mixed venous-arterial carbon dioxide (Pmv-a CO2 gap) will be obtained from tip of pulmonary artery catheter All blood gases measurements will be made using a Cooximeter (ABL 700, Radiometer, Copenhagen, Denmark). Immediately after blood samples withdrawal, mean arterial blood pressure (MAP), heart rate, and cardiac output (CO) and arterial lactate will be recorded. Cardiac output will be determined by thermodilution technique using the PA catheter (Abbott Critical Care Systems, North Chicago).

Conditions

Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

co2 gap

arterial and central venous blood gases to measure Co2 gap

Group Type: OTHER

arterial and central venous blood gases

Intervention Type: DIAGNOSTIC_TEST

withdrawal of arterial and central venous blood gases to measure Co2 gap

Interventions

arterial and central venous blood gases

withdrawal of arterial and central venous blood gases to measure Co2 gap

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed mohamed mokhtar, M.D

Role: STUDY_DIRECTOR

kasralainy faculty of medicine, Cairo university

Locations

Kasr Alainy Hospital , Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

References

Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.

Reference Type: BACKGROUND

PMID: 10840602 (View on PubMed)

Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.

Reference Type: BACKGROUND

PMID: 17925428 (View on PubMed)

Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Changes in central venous saturation after major surgery, and association with outcome. Crit Care. 2005;9(6):R694-9. doi: 10.1186/cc3888. Epub 2005 Nov 8.

Reference Type: BACKGROUND

PMID: 16356220 (View on PubMed)

ELAyashy M, Hosny H, Hussein A, AbdelAal Ahmed Mahmoud A, Mukhtar A, El-Khateeb A, Wagih M, AboulFetouh F, Abdelaal A, Said H, Abdo M. The validity of central venous to arterial carbon dioxide difference to predict adequate fluid management during living donor liver transplantation. A prospective observational study. BMC Anesthesiol. 2019 Jun 22;19(1):111. doi: 10.1186/s12871-019-0776-9.

Reference Type: DERIVED

PMID: 31228943 (View on PubMed)

Other Identifiers

N - 21- 2017

Identifier Type: -

Identifier Source: org_study_id