Blood PressureIMPROVENCT03442907
Personalized Blood Pressure Management
A study testing 24 hour blood pressure measurement, fluids, vasopressors in people with Blood Pressure and Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery. Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Blood Pressure, Intraoperative Hypotension, Postoperative Complications
- What is being tested?
- 24 hour blood pressure measurement, fluids, vasopressors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 31 Jan 2020
- 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 50 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 50 years
- ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
- duration of intervention in general anesthesia at least 90 minutes
Who cannot join
- Pregnancy
- Emergency procedures
- Surgery requiring controlled hypotension (e.g., aneurysm)
- Cerebrovascular events in the past medical history
- Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
- Pre-existing dementia (anamnesis)
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- kidney transplant
- dialysis-dependent renal insufficiency (KDIGO criteria)
- no patient consent
- failure to meet the inclusion criteria
- Impossibility of 24-h blood pressure measurement
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.
- Being tested
- 24 hour blood pressure measurement, fluids, vasopressors, Standard of Care
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour blood pressure measurement, fluids, vasopressorsProcedure or surgery
Targeting individual blood blood pressure values during surgical procedures
Standard of CareProcedure or surgery
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement.
To achieve the blood pressure target, fluid or vasoactive substances will be used. Receives: Procedure: 24 hour blood pressure measurement, fluids, vasopressors |
| Control group | Active comparator | Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf. Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: Incidence of POCD or delirium
POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.
Measured: 3rd-7th postoperative day
Secondary outcomes (5)
Kidney function
Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)
Measured: 24, 48 and 72 hrs after surgery
cardiac ischemia
high-sensitive troponin T measurements are performed prior and 6 hours after surgery
Measured: 6 hours after surgery
length of hospital stay
Measured: 30 days
30-day mortality
Measured: 30 days
30-day morbidity
European perioperative outcome definitions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2018
- Primary completion10 Oct 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442907
- Sponsor's protocol ID
- IMPROVE-1.0
- Acronym
- IMPROVE
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.
PubMed 39050403
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
- ClinicalTrials.gov ID
- NCT03442907
- Acronym / sponsor ID
- IMPROVE / IMPROVE-1.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 22 Feb 2018 (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.
The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: 24 hour blood pressure measurement, fluids, vasopressorsThe intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement. To achieve the blood pressure target, fluid or vasoactive substances will be used. |
| Control group | Active comparator | Procedure: Standard of CareStudy patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf. |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 50 years
- ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
- duration of intervention in general anesthesia at least 90 minutes
Key exclusion criteria (11 listed)
- Pregnancy
- Emergency procedures
- Surgery requiring controlled hypotension (e.g., aneurysm)
- Cerebrovascular events in the past medical history
- Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
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 |
|---|---|---|
| 24 hour blood pressure measurement, fluids, vasopressorsTargeting individual blood blood pressure values during surgical procedures | Procedure or surgery | Study group |
| Standard of CareTreatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf | Procedure or surgery | Control group |
Primary outcome
Composite endpoint: Incidence of POCD or delirium
Time frame: 3rd-7th postoperative day
POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.
5 secondary outcomes
Kidney function
Time frame: 24, 48 and 72 hrs after surgery
cardiac ischemia
Time frame: 6 hours after surgery
length of hospital stay
Time frame: 30 days
30-day mortality
Time frame: 30 days
30-day morbidity
Time frame: 30 days
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 26 Jan 2021.
- Derived from this study: PubMed 39050403Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 hour blood pressure measurement, fluids, vasopressors in people with Blood Pressure and Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 11 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 26 Jan 2021. 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 Germany. 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?
Composite endpoint: Incidence of POCD or delirium (time frame: 3rd-7th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442907, which also lists 1 linked publication.
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 26 Jan 2021.