Blood PressureNCT02832596
Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia
A study testing Norepinephrine and Maintained blood pressure in people with Blood Pressure and Anesthesia, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The arterial blood pressure is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Blood Pressure, Anesthesia
- What is being tested?
- Norepinephrine and Maintained blood pressure
- 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
- Oct 2016to 20 Aug 2019
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective coronary artery surgery patients
Who cannot join
- Age under 40 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.
About this study
Official title: Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia, a Randomised Clinical Trial
The arterial blood pressure is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the increase in 125 iodine-labeled human serum albumine (125I-HSA) measured plasma volume.
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. Equal anesthesia in both groups will be monitored. No fluids will be infused.
Changes in vascular resistance and cardiac output will be measured with thermodilution and changes in plasma volume will be measured with 125I-HSA.
Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will be evaluated by thromboelastography/multiplate.
- Conditions
- Blood Pressure, Anesthesia
- Being tested
- Norepinephrine, Maintained blood pressure
- Keywords
- Anesthesia, Blood pressure, Plasma Volume, Vasopressor agents, Coronary artery bypass, Glycocalyx, ANP, Coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Vasopressor
Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion
Maintained blood pressureProcedure or surgery
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: Drug: Norepinephrine; Procedure: Maintained blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.
To assess if the increase in plasma volume measured by 125I-HSA can be reduced by maintaining the blood pressure with vasopressor infusion.
Measured: 50 minutes from anesthesia induction
Secondary outcomes (2)
Difference in 125I-HSA leakage
To assess if there is a difference in 125I-HSA leakage in between the control and intervention groups before and after anaesthesia induction
Measured: 50 minutes from anesthesia induction
ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM
To assess if there is a difference in the plasma concentration of ANP, heparan sulphate, thrombomodulin, fibrinogen and ROTEM before and after anaesthesia induction in the intervention group compared to the control group
Measured: 50 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 posted14 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
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.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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 (actual)
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, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832596
- Sponsor's protocol ID
- Plasmavolume TDamen
- Status last verified
- Apr 2020
- First submitted
- 11 Jul 2016
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia, a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02832596
- Acronym / sponsor ID
- Plasmavolume TDamen
- Conditions
- Blood Pressure, Anesthesia
- Keywords
- Anesthesia, Blood pressure, Plasma Volume, Vasopressor agents, Coronary artery bypass, Glycocalyx, ANP, Coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 14 Jul 2016 (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 is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the increase in 125 iodine-labeled human serum albumine (125I-HSA) measured plasma volume.
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. Equal anesthesia in both groups will be monitored. No fluids will be infused.
Changes in vascular resistance and cardiac output will be measured with thermodilution and changes in plasma volume will be measured with 125I-HSA.
Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will be evaluated by thromboelastography/multiplate.
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 | Drug: Norepinephrine, Procedure: Maintained blood pressureOrdinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion |
Who may qualify
- Ages
- 40 to 90 years
- 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 40 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 |
|---|---|---|
| NorepinephrineAlso: VasopressorOrdinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion | Drug | Maintained blood pressure |
| Maintained blood pressureNorepinephrine therapy to maintain preanesthesia blood pressure | Procedure or surgery | Maintained blood pressure |
Primary outcome
The change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction.
Time frame: 50 minutes from anesthesia induction
To assess if the increase in plasma volume measured by 125I-HSA can be reduced by maintaining the blood pressure with vasopressor infusion.
2 secondary outcomes
Difference in 125I-HSA leakage
Time frame: 50 minutes from anesthesia induction
ANP, heparan sulphate, thrombomodulin, fibrinogen, ROTEM
Time frame: 50 minutes from anesthesia induction
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 30 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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
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 Norepinephrine and Maintained blood pressure in people with Blood Pressure and Anesthesia, 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: finished, as of the sponsor's last update on 30 Apr 2020. 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?
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 change of plasma volume measured by 125I-HSA before anesthesia induction until 50 minutes after anesthesia induction. (time frame: 50 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 30 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.