Critically Ill Surgical PatientsNCT07295795
Blood Sampling Pre- and Post-Propofol Administration to Characterize the Blood Proteome Using Different Research Assays
An observational study of Critically Ill Surgical Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critically Ill Surgical Patients
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 13 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol. Male or female aged 18 years or older.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.
- Male or female aged 18 years or older.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Surgical procedure not utilizing propofol
- Hemoglobin < 7 ug/dL at the time of enrollment
- Inability to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Blood Sampling Pre- and Post-Propofol to Characterize the Blood Proteome Using Different Research Assays
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.
Read more
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.
Read the detailed description
Study Description:
This is a blood procurement research protocol. The study will collect a total of 3 blood samples at 2 timepoints (1 blood sample prior to propofol and 2 after propofol dosing) from up to 10 participants pre- and post-induction of anesthesia with propofol to characterize the effects of propofol on the measurement of the blood proteome using different research assays. Blood samples will be withdrawn from existing intravenous access so that no additional interventions are required. The PI, or team designee, will have a discussion with the primary surgeon to determine suitability of the potential participant for eligibility. If determined suitable, the participant will be recruited by invitation. All potential participants will be consented to a primary surgical protocol; consent to this protocol will be secondary and obtained prior to the procedure.
Objectives:
Primary Objective:
The primary objective of this research protocol is to procure blood samples from participants prior to and post propofol administration to quantify the impact of propofol on the quantification of the blood proteome.
Endpoints:
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarker assays Pre- and Post-Propofol administration.
- Conditions
- Critically Ill Surgical Patients
- Keywords
- Propofol, Blood Proteome, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill surgical patients | Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarkers assays pre- and post-propofol.
The investigators would like to use the O-link Explore HT and SomaScan Discovery v4.1assay on samples from participants who are critically ill. In order to do this understanding, the impact of propofol on each analyte must be understood as there is potential for interference with propofol in each sample.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start10 Feb 2026
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Surgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew J Mannes, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295795
- Sponsor's protocol ID
- 10002371
- Other IDs
- 002371-CC
- Status last verified
- 17 Apr 2026
- First submitted
- 19 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sampling Pre- and Post-Propofol to Characterize the Blood Proteome Using Different Research Assays
- ClinicalTrials.gov ID
- NCT07295795
- Acronym / sponsor ID
- 10002371
- Conditions
- Critically Ill Surgical Patients
- Keywords
- Propofol, Blood Proteome, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
This is a blood procurement research protocol. The study will collect a total of 3 blood samples at 2 timepoints (1 blood sample prior to propofol and 2 after propofol dosing) from up to 10 participants pre- and post-induction of anesthesia with propofol to characterize the effects of propofol on the measurement of the blood proteome using different research assays. Blood samples will be withdrawn from existing intravenous access so that no additional interventions are required. The PI, or team designee, will have a discussion with the primary surgeon to determine suitability of the potential participant for eligibility. If determined suitable, the participant will be recruited by invitation. All potential participants will be consented to a primary surgical protocol; consent to this protocol will be secondary and obtained prior to the procedure.
Objectives:
Primary Objective:
The primary objective of this research protocol is to procure blood samples from participants prior to and post propofol administration to quantify the impact of propofol on the quantification of the blood proteome.
Endpoints:
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarker assays Pre- and Post-Propofol administration.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill surgical patients | – | –Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol. Male or female aged 18 years or older.
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.
- Male or female aged 18 years or older.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Surgical procedure not utilizing propofol
- Hemoglobin < 7 ug/dL at the time of enrollment
- Inability to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarkers assays pre- and post-propofol.
Time frame: 1 year
The investigators would like to use the O-link Explore HT and SomaScan Discovery v4.1assay on samples from participants who are critically ill. In order to do this understanding, the impact of propofol on each analyte must be understood as there is potential for interference with propofol in each sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Mannes, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Surgical Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarkers assays pre- and post-propofol. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.