NCT04792242

Brief Summary

  1. 1.Primary (main):
  2. 2.Secondary (subsidiary):

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

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

Study Start

First participant enrolled

November 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 7, 2021

Last Update Submit

March 18, 2021

Conditions

Major Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

  • Post operative mortality

    early post operative mortality

    30 days

Secondary Outcomes (1)

  • post operative organ failure

    30 days

Study Arms (2)

goal directed therapy

ACTIVE COMPARATOR

svo2,haematocrite value,urine output,mean arterial pressure and central venous pressure

Device: cv line insertionDevice: Urinary catheter insertion

PCO2 gap algorithm

ACTIVE COMPARATOR

PCO2 gap,haematocrite value,Spo2,cardiac index

Device: cv line insertionDevice: Urinary catheter insertionDevice: Arterial line

Interventions

cv line insertionDEVICE

Svo2 and central venous pressure measurements

PCO2 gap algorithmgoal directed therapy
Urinary catheter insertionDEVICE

urine output measurement

PCO2 gap algorithmgoal directed therapy
Arterial lineDEVICE

Arterial blood gases measurment

PCO2 gap algorithm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues

You may not qualify if:

  • patients who will refuse to continue on research patients who will not be admitted post operative in the ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Luxor, Qena Governorate, 83523, Egypt

Location

MeSH Terms

Interventions

Urinary CatheterizationVascular Access Devices

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative TechniquesCathetersEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: case control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidat

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 10, 2021

Study Start

November 10, 2019

Primary Completion

December 21, 2020

Study Completion

March 7, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

EG(1)