NCT02477982

Brief Summary

The primary objective of this study is to develop a descriptive and predictive pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and lean patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 14, 2015

Last Update Submit

June 18, 2015

Conditions

Obesity

Keywords

PropofolCardiopulmonary BypassPharmacokineticsObesity

Outcome Measures

Primary Outcomes (4)

  • Clearance (Cl/)

    intraoperative

  • volume of distribution of first compartment (V1)

    intraoperative

  • Clearance from first to second compartment (Q1)

    intraoperative

  • volume of distribution of second compartment (V1)

    intraoperative

Study Arms (2)

control group

BMI ≤ 25 kgm-2

obese group

BMI ≥ 30 kgm-2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective cardiac surgery using Cardiopulmonary bypass with moderate hypothermia (defined as core body temperature of 28-32oC).

You may qualify if:

  • BMI ≤ 25 kg/m2 or ≥ 30 kg/m2.
  • Propofol based maintenance of anaesthesia during CPB.

You may not qualify if:

  • Pregnant women or lactating mothers.
  • Renal (serum creatinine concentration\>1.5 or creatinine Cl ≤ 30 ml/min) or hepatic disorders (total bilirubin \>1.5 or ≥ 2 fold increase in alanine transferase (ALT) or aspartate transferase (AST).
  • Systemic infections.
  • Hypoalbuminemia (defined as albumin \<3.5 gm/dL).
  • Known history of alcohol or drug abuse.
  • Administration of aspirin on the day of surgery or warfarin within 7 days preceding surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant at clinical pharmacy department faculty of pharmacy

Study Record Dates

First Submitted

June 14, 2015

First Posted

June 23, 2015

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

June 23, 2015

Record last verified: 2015-06