- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123172
The Validity of Central Venous to Arterial Co2 Difference During Living Donor Liver Transplantation
The Validity of Central Venous to Arterial Carbon Dioxide Difference to Predict Adequate Fluid Resuscitation During Living Donor Liver Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Kasr Alainy Hospital , Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: co2 gap
arterial and central venous blood gases to measure Co2 gap
|
withdrawal of arterial and central venous blood gases to measure Co2 gap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between the PPV(pulse pressure variation) and Pcv-a CO2 (central venous to arterial) gap
Time Frame: baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
changes in central venous to arterial co2 gap with fluid status
|
baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between the PPV(pulse pressure variation) and Pmv-a CO2(mixed venous to arterial) gaps
Time Frame: baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
changes in mixed venous to arterial co2 gap with fluid status
|
baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
validity of venous-arterial CO2 gap to predict fluid Responsiveness.
Time Frame: baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
sensitivity and specificity of co2 gap to detect patients who are fluid responder and non responder using area under ROC curve
|
baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
correlation between the CO and both Pcv-a CO2 and Pmv-a CO2 gaps
Time Frame: baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
changes in mixed and central venous to arterial co2 gap with cardiac output changes
|
baseline 5 min after induction of anesthesia, immediately after insertion of PAC; 30 minutes after the dissection phase; 30 minutes after anhepatic phase; 30 minutes after unclamping
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N - 21- 2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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