NCT03228329

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

July 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

July 13, 2017

Last Update Submit

December 21, 2018

Conditions

Liver Transplantation

Keywords

cardiometrystroke volumeliver transplantation

Outcome Measures

Primary Outcomes (2)

  • stroke volume

    record stroke volume assessed by noninvasive cardiometry and TEE

    5 minutes after reperfusion.

  • stroke volume

    record stroke volume assessed by noninvasive cardiometry and TEE

    15 minutes after dissection phase.

Secondary Outcomes (2)

  • stroke volume variation

    5 minutes after reperfusion.

  • stroke volume variation

    15 minutes after dissection phase

Study Arms (1)

cardiometry

OTHER

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

Other: fluid boluses

Interventions

fluid bolusesOTHER

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

cardiometry

Eligibility Criteria

Age18 Years - 70 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

  • 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. doi: 10.1016/s0041-1345(98)00465-5. No abstract available.

    PMID: 9723316BACKGROUND

  • Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. doi: 10.1016/s0140-6736(94)92276-4. No abstract available.

    PMID: 7848422BACKGROUND

  • Mukhtar AM, Elayashy M, Sayed AH, Obaya GM, Eladawy AA, Ali MA, Dahab HM, Khalaf DZ, Mohamed MA, Elfouly AH, Behairy GM, Abdelaal AA. Validation of electrical velocimetry in resuscitation of patients undergoing liver transplantation. Observational study. J Clin Monit Comput. 2020 Apr;34(2):271-276. doi: 10.1007/s10877-019-00313-z. Epub 2019 Apr 19.

    PMID: 31004273DERIVED

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
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 24, 2017

Study Start

August 10, 2017

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations

EG(1)