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Trial record 2 of 671 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT03123172
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital

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

Condition or disease Intervention/treatment Phase
Liver Transplantation Diagnostic Test: arterial and central venous blood gases Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Validity of Central Venous to Arterial Carbon Dioxide Difference to Predict Adequate Fluid Resuscitation During Living Donor Liver Transplantation
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
co2 gap
arterial and central venous blood gases to measure Co2 gap
Diagnostic Test: arterial and central venous blood gases
withdrawal of arterial and central venous blood gases to measure Co2 gap




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123172


Locations
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Egypt
Kasr Alainy Hospital , Faculty of Medicine
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: ahmed mohamed mokhtar, M.D kasralainy faculty of medicine, Cairo university

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohamed Elayashy Mohamed Ahmed Hassan, clinical professor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03123172     History of Changes
Other Study ID Numbers: N - 21- 2017
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital:
co2 gap
PPV
resuscitation
liver transplantation