Protocol Details

Blood Sampling Pre- and Post-Propofol to Characterize the Blood Proteome Using Different Research Assays

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

002371-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children;
Fetuses;
Pregnant Women

Keywords

Propofol;
Blood Proteome;
Biomarkers

Recruitment Keyword(s)

None

Condition(s)

Critically Ill Surgical Patients

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Background:

Propofol is a drug that helps people fall asleep quickly and stay asleep during surgery, so they do not feel any pain. This drug is also used to sedate critically ill people who must be on a ventilator (a machine to help them breathe). To better understand how to interpret blood tests in these ill people, researchers need to know more about how the drug itself may change proteins in the blood.

Objective:

To collect blood samples from people before and after propofol is administered for surgery.

Eligibility:

People aged 18 years or older who are scheduled for surgery that requires sedation with propofol.

Design:

Participants will have data collected. This data will include age, sex, and ethnicity. They will be asked about their medical history.

Participants will have blood samples collected before and after they receive propofol for their surgery. The blood will be collected from lines already installed for the surgery; no new needlesticks will be done for the study. A total of 3 teaspoons of blood will be drawn.

The samples will be compared to each other to look for any changes caused by the drug.

No follow-up visits are required.

Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form

2. Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.

3. Male or female aged 18 years or older.

4. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1. Surgical procedure not utilizing propofol

2. Hemoglobin < 7 ug/dL at the time of enrollment

3. Inability to sign consent


Citations:

Not Provided

Contacts:

Principal Investigator

Referral Contact

For more information:

Andrew J. Mannes, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2C744
10 CENTER DR
BETHESDA MD 20892
(301) 594-3427
amannes@cc.nih.gov
Tracy S. Williams, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 2C525
10 Center Drive
Bethesda, Maryland 20892
(301) 448-5366
tracy.williams@nih.gov
Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT07295795
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