NCT05004545

Brief Summary

Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 10, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

4.3 years

First QC Date

July 16, 2021

Last Update Submit

August 9, 2021

Conditions

Hemodynamic Instability

Keywords

PropofolSevofluranehemodynamic stabilityLactate level

Outcome Measures

Primary Outcomes (1)

  • Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters

    The mean pre-cross clamp lactate level and post- rewarming lactate level will be calculated to see the effect of this on the CABG patients hemodynamics during CBP

    06 months

Study Arms (2)

group 1 Profol Infusion to CABG patients to check lactate level

EXPERIMENTAL

Propofol infusion according to bodyweight will be given to check lactate level on CPB

Drug: Propofol

sevoflurane will be given to group 2 to check lacate level

ACTIVE COMPARATOR

Sevoflurane MAC % will be given to CABG patients to check lactate level

Drug: Propofol

Interventions

PropofolDRUG

Propofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients

group 1 Profol Infusion to CABG patients to check lactate levelsevoflurane will be given to group 2 to check lacate level

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CABG

You may not qualify if:

  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery ICU

Multan, Punjab Province, 66100, Pakistan

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Kaneez Ume Farwa, FCPS

    Chaudhry Pervaiz Elahi Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaneez Ume Farwa, FCPS

CONTACT

+923356787214farwatirmizi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 13, 2021

Study Start

June 10, 2017

Primary Completion

September 20, 2021

Study Completion

December 30, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Ok

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Soon
Access Criteria
Ok

Locations

PA(1)