Blood PressureNCT02412189
Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia
A study testing Maintained blood pressure and Norepinephrine in people with Blood Pressure and Hematocrit Change, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Hematocrit Change, Anesthesia
- What is being tested?
- Maintained blood pressure and Norepinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective coronary artery surgery patients
Who cannot join
- Age under 18 years
- untreated hypertension
- a reduced left ventricular systolic ejection fraction of 45 % or less
- diabetes mellitus
- former stroke and/or a known carotid artery stenosis.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Andreas Nygren, MD PHD, +46313427444, andreas.nygren@aniv.gu.se
About this study
The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the decrease in hematocrit.
Read the detailed description
24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Arterial blood gas will be analysed every ten minutes. Equal anesthesia in both groups will be monitored. No fluids will be infused. Noninvasive continuous hemoglobin measurement (SpHb) will be measured.
- Conditions
- Blood Pressure, Hematocrit Change, Anesthesia
- Being tested
- Maintained blood pressure, Norepinephrine
- Keywords
- Anesthesia, Blood pressure, Plasma volume, Vasopressor agents, Continuous noninvasive hemoglobin measurement, Coronary artery bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintained blood pressureProcedure or surgery
Norepinephrine therapy to maintain preanesthesia blood pressure
NorepinephrineDrug
Also called Vasopressor
Norepinephrine therapy to maintain preanesthesia blood pressure
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Ordinary anesthesia, mean arterial pressure allowed to decrease to 60 mmHg. If it is lower the patients will receive a norepinephrine infusion in order to raise the mean arterial pressure to 60 mmHg. |
| Maintained blood pressure | Active comparator | Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion Receives: Procedure: Maintained blood pressure; Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude and dynamics of the decrease in hematocrit during anesthesia induction
Measured: 70 minutes from anesthesia induction
Secondary outcomes (1)
Reduced hematocrit decrease by vasopressor infusion maintained blood pressure
To assess if the decrease in hematocrit can be reduced, by maintaining the blood pressure with vasopressor infusion
Measured: 70 minutes from anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Damén, Sahlgrenska University Hospital
- Investigators
- Andreas Nygren, MD PHD, Principal investigator, Sweden: Sahlgrenska University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412189
- Sponsor's protocol ID
- TDamen
- Status last verified
- Apr 2015
- First submitted
- 10 Mar 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia
- ClinicalTrials.gov ID
- NCT02412189
- Acronym / sponsor ID
- TDamen
- Conditions
- Blood Pressure, Hematocrit Change, Anesthesia
- Keywords
- Anesthesia, Blood pressure, Plasma volume, Vasopressor agents, Continuous noninvasive hemoglobin measurement, Coronary artery bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 9 Apr 2015 (estimated)
- 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.
The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the decrease in hematocrit.
Detailed description
24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Arterial blood gas will be analysed every ten minutes. Equal anesthesia in both groups will be monitored. No fluids will be infused. Noninvasive continuous hemoglobin measurement (SpHb) will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Ordinary anesthesia, mean arterial pressure allowed to decrease to 60 mmHg. If it is lower the patients will receive a norepinephrine infusion in order to raise the mean arterial pressure to 60 mmHg. |
| Maintained blood pressure | Active comparator | Procedure: Maintained blood pressure, Drug: NorepinephrineOrdinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective coronary artery surgery patients
Key exclusion criteria (5 listed)
- Age under 18 years
- untreated hypertension
- a reduced left ventricular systolic ejection fraction of 45 % or less
- diabetes mellitus
- former stroke and/or a known carotid artery stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintained blood pressureNorepinephrine therapy to maintain preanesthesia blood pressure | Procedure or surgery | Maintained blood pressure |
| NorepinephrineAlso: VasopressorNorepinephrine therapy to maintain preanesthesia blood pressure | Drug | Maintained blood pressure |
Primary outcome
The magnitude and dynamics of the decrease in hematocrit during anesthesia induction
Time frame: 70 minutes from anesthesia induction
1 secondary outcome
Reduced hematocrit decrease by vasopressor infusion maintained blood pressure
Time frame: 70 minutes from anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
Andreas Nygren, MD PHD principal investigator
Sweden: Sahlgrenska University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintained blood pressure and Norepinephrine in people with Blood Pressure and Hematocrit Change, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tor Damén, MD (+46313427873, tor.damen@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The magnitude and dynamics of the decrease in hematocrit during anesthesia induction (time frame: 70 minutes from anesthesia induction). 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 9 Apr 2015.