NCT03123172

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

August 23, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

March 31, 2017

Last Update Submit

August 21, 2017

Conditions

Liver Transplantation

Keywords

co2 gapPPVresuscitationliver transplantation

Outcome Measures

Primary Outcomes (1)

  • correlation between the PPV(pulse pressure variation) and Pcv-a CO2 (central venous to arterial) gap

    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 Outcomes (3)

  • correlation between the PPV(pulse pressure variation) and Pmv-a CO2(mixed venous to arterial) gaps

    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.

    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

    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

Study Arms (1)

co2 gap

OTHER

arterial and central venous blood gases to measure Co2 gap

Diagnostic Test: arterial and central venous blood gases

Interventions

arterial and central venous blood gasesDIAGNOSTIC_TEST

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

co2 gap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA II to IV patients with end-stage liver disease
  • patients undergoing orthotopic living donor liver transplantation
  • age \> 18 years

You may not qualify if:

  • acute fulminant liver failure
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (4)

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

    PMID: 10840602BACKGROUND

  • 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.

    PMID: 17925428BACKGROUND

  • 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.

    PMID: 16356220BACKGROUND

  • 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.

    PMID: 31228943DERIVED

Study Officials

  • ahmed mohamed mokhtar, M.D

    kasralainy faculty of medicine, Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 21, 2017

Study Start

April 25, 2017

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

August 23, 2017

Record last verified: 2017-04

Locations

EG(1)