Blood PressureIMPROVENCT05416944
Perioperative Personalized Blood Pressure Management: IMPROVE-multi
A study testing Personalized blood pressure management in people with Blood Pressure and Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Intraoperative Hypotension, Postoperative Complications
- What is being tested?
- Personalized blood pressure management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 participants
- Where
- 1 siteGermany
- Study dates
- 26 Feb 2023to 25 Jul 2024
- 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
- Consenting patients ≥45 years scheduled for elective major abdominal surgery under general anesthesia that is expected to last ≥90 minutes AND
- Presence of ≥1 of the following high-risk criteria:
- exercise tolerance <4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
- renal impairment (serum creatinine ≥1.3 mg/dL or estimated glomerular filtration rate <90 mL/min/1.73 m2 within the last 6 months)
- coronary artery disease (any stage)
- chronic heart failure (New York Heart Association Functional Classification ≥II)
Show all 18Show fewer
- valvular heart disease (moderate or severe)
- history of stroke
- peripheral arterial occlusive disease (any stage)
- chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
- diabetes mellitus requiring oral hypoglycemic agent or insulin
- immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold])
- liver cirrhosis (any Child-Pugh class)
- body mass index ≥30 kg/m2
- current smoking or 15 pack-year history of smoking
- age ≥65 years
- expected anesthesia duration >180 minutes
- B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months
Who cannot join
- emergency surgery
- surgery: nephrectomy, liver or kidney transplantation
- status post transplantation of kidney, liver, heart, or lung
- sepsis (according to current Sepsis-3 definition)
- American Society of Anesthesiologists physical status classification V or VI
- pregnancy
- patients on renal replacement therapy
- impossibility of preoperative automated blood pressure monitoring
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial
Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.
- Conditions
- Blood Pressure, Intraoperative Hypotension, Postoperative Complications, Surgery, Anesthesia
- Being tested
- Personalized blood pressure management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized blood pressure managementOther
Personalized blood pressure management: Intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Routine management (control) group | No intervention | Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients assigned to the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. |
| Personalized management (intervention) group | Experimental | In patients randomized to the personalized management group, intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. The perioperative trial intervention period starts with the beginning of the induction of general anesthesia and ends two hours after surgery ends. Receives: Other: Personalized blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of major postoperative complications
Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery
Measured: Postoperative Day 7
Secondary outcomes (33)
Composite outcome of major postoperative complications
Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 3 days after surgery
Measured: Postoperative Day 3
Postoperative acute kidney injury
Incidence of acute kidney injury within 3 days after surgery
Measured: Postoperative Day 3
Postoperative acute kidney injury
Incidence of acute kidney injury within 7 days after surgery
Measured: Postoperative Day 7
Postoperative acute myocardial injury (including myocardial infarction)
Incidence of acute myocardial injury (including myocardial infarction) within 3 days after surgery
Measured: Postoperative Day 3
Postoperative acute myocardial injury (including myocardial infarction)
Incidence of acute myocardial injury (including myocardial infarction) within 7 days after surgery
Measured: Postoperative Day 7
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 3 days after surgery
Measured: Postoperative Day 3
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 7 days after surgery
Measured: Postoperative Day 7
Postoperative death
Incidence of death within 3 days after surgery
Measured: Postoperative Day 3
Postoperative death
Incidence of death within 7 days after surgery
Measured: Postoperative Day 7
Composite outcome of long-term postoperative complications
Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery
Measured: Postoperative Day 30
Composite outcome of long-term postoperative complications
Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery
Measured: Postoperative Day 90
Postoperative need for renal replacement therapy
Incidence of need for renal replacement therapy within 30 days after surgery
Measured: Postoperative Day 30
Postoperative need for renal replacement therapy
Incidence of need for renal replacement therapy within 90 days after surgery
Measured: Postoperative Day 90
Postoperative myocardial infarction
Incidence of myocardial infarction within 30 days after surgery
Measured: Postoperative Day 30
Postoperative myocardial infarction
Incidence of myocardial infarction within 90 days after surgery
Measured: Postoperative Day 90
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 30 days after surgery
Measured: Postoperative Day 30
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 90 days after surgery
Measured: Postoperative Day 90
Postoperative death
Incidence of death within 30 days after surgery
Measured: Postoperative Day 30
Postoperative death
Incidence of death within 90 days after surgery
Measured: Postoperative Day 90
Postoperative infectious complications
Collapsed incidence of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery
Measured: Postoperative Day 7
Postoperative fever
Incidence of fever within 7 days after surgery
Measured: Postoperative Day 7
Postoperative respiratory infection
Incidence of respiratory infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative neurological infection
Incidence of neurological infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative urinary system infection
Incidence of urinary system infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile
Incidence of colitis or infection with Clostridium difficile within 7
Measured: Postoperative Day 7
Postoperative endometritis
Incidence of endometritis within 7 days after surgery
Measured: Postoperative Day 7
Postoperative surgical site infection
Incidence of surgical site infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative deep incisional surgical site infection
Incidence of deep incisional surgical site infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative organ or space surgical site infection
Incidence of organ or space surgical site infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative unknown infection with pathogenic organisms in tissue or fluid
Incidence of unknown infection with pathogenic organisms in tissue or fluid
Measured: Postoperative Day 7
Postoperative sepsis
Incidence of sepsis within 7 days after surgery
Measured: Postoperative Day 7
Hospital discharge
Time-to-event outcome with the event "hospital discharge"
Measured: Postoperative Day 90
Unplanned hospital re-admission
Incidence of unplanned hospital re-admission within 30 days after surgery
Measured: Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Feb 2023
- Primary completion25 May 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Bernd Saugel, M.D., Principal investigator, Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416944
- Sponsor's protocol ID
- ZKSJ0147
- Acronym
- IMPROVE
- Status last verified
- Jun 2025
- First submitted
- 16 May 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Saugel B, Meidert AS, Brunkhorst FM, Bischoff R, Esser J, Mattis M, Naue P, Vogel K, Bergholz A, Flick M, Kroker A, Muller DX, Thomsen KK, Vokuhl C, Wegge M, Bratke S, Graessner M, Jungwirth B, Schmid S, Grundmann CD, Wischermann JM, Kellner P, Steinhaus M, Grusser L, Coldewey SM, Zacharowski K, Meybohm P, Habicher M, Zarbock A, Zitzmann A, Letz S, Neumann C, Larmann J, Renne T, Krause L, Vettorazzi E, Zapf A, Carlstedt A, Sessler DI, Kouz K; IMPROVE-multi Trial Group. Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial. JAMA. 2025 Dec 2;334(21):1893-1904. doi: 10.1001/jama.2025.17235.
PubMed 41076588Bergholz A, Meidert AS, Flick M, Krause L, Vettorazzi E, Zapf A, Brunkhorst FM, Meybohm P, Zacharowski K, Zarbock A, Sessler DI, Kouz K, Saugel B. Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi). Trials. 2022 Nov 17;23(1):946. doi: 10.1186/s13063-022-06854-0.
PubMed 36397173
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT05416944
- Acronym / sponsor ID
- IMPROVE / ZKSJ0147
- Conditions
- Blood Pressure, Intraoperative Hypotension, Postoperative Complications, Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,272 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Jena University Hospital, The Cleveland Clinic
- Study start
- 26 Feb 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 14 Jun 2022 (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.
Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine management (control) group | No intervention | –Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients assigned to the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. |
| Personalized management (intervention) group | Experimental | Other: Personalized blood pressure managementIn patients randomized to the personalized management group, intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. The perioperative trial intervention period starts with the beginning of the induction of general anesthesia and ends two hours after surgery ends. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Consenting patients ≥45 years scheduled for elective major abdominal surgery under general anesthesia that is expected to last ≥90 minutes AND
- Presence of ≥1 of the following high-risk criteria:
Key exclusion criteria (8 listed)
- emergency surgery
- surgery: nephrectomy, liver or kidney transplantation
- status post transplantation of kidney, liver, heart, or lung
- sepsis (according to current Sepsis-3 definition)
- American Society of Anesthesiologists physical status classification V or VI
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 |
|---|---|---|
| Personalized blood pressure managementPersonalized blood pressure management: Intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. | Other | Personalized management (intervention) group |
Primary outcome
Composite outcome of major postoperative complications
Time frame: Postoperative Day 7
Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery
33 secondary outcomes
Composite outcome of major postoperative complications
Time frame: Postoperative Day 3
Postoperative acute kidney injury
Time frame: Postoperative Day 3
Postoperative acute kidney injury
Time frame: Postoperative Day 7
Postoperative acute myocardial injury (including myocardial infarction)
Time frame: Postoperative Day 3
Postoperative acute myocardial injury (including myocardial infarction)
Time frame: Postoperative Day 7
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 3
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 7
Postoperative death
Time frame: Postoperative Day 3
Postoperative death
Time frame: Postoperative Day 7
Composite outcome of long-term postoperative complications
Time frame: Postoperative Day 30
Composite outcome of long-term postoperative complications
Time frame: Postoperative Day 90
Postoperative need for renal replacement therapy
Time frame: Postoperative Day 30
Postoperative need for renal replacement therapy
Time frame: Postoperative Day 90
Postoperative myocardial infarction
Time frame: Postoperative Day 30
Postoperative myocardial infarction
Time frame: Postoperative Day 90
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 30
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 90
Postoperative death
Time frame: Postoperative Day 30
Postoperative death
Time frame: Postoperative Day 90
Postoperative infectious complications
Time frame: Postoperative Day 7
Postoperative fever
Time frame: Postoperative Day 7
Postoperative respiratory infection
Time frame: Postoperative Day 7
Postoperative neurological infection
Time frame: Postoperative Day 7
Postoperative urinary system infection
Time frame: Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile
Time frame: Postoperative Day 7
Postoperative endometritis
Time frame: Postoperative Day 7
Postoperative surgical site infection
Time frame: Postoperative Day 7
Postoperative deep incisional surgical site infection
Time frame: Postoperative Day 7
Postoperative organ or space surgical site infection
Time frame: Postoperative Day 7
Postoperative unknown infection with pathogenic organisms in tissue or fluid
Time frame: Postoperative Day 7
Postoperative sepsis
Time frame: Postoperative Day 7
Hospital discharge
Time frame: Postoperative Day 90
Unplanned hospital re-admission
Time frame: Postoperative Day 30
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 16 Oct 2026.
- Derived from this study: PubMed 41076588Saugel B, Meidert AS, Brunkhorst FM, Bischoff R, Esser J, Mattis M, Naue P, Vogel K, Bergholz A, Flick M, Kroker A, Muller DX, Thomsen KK, Vokuhl C, Wegge M, Bratke S, Graessner M, Jungwirth B, Schmid S, Grundmann CD, Wischermann JM, Kellner P, Steinhaus M, Grusser L, Coldewey SM, Zacharowski K, Meybohm P, Habicher M, Zarbock A, Zitzmann A, Letz S, Neumann C, Larmann J, Renne T, Krause L, Vettorazzi E, Zapf A, Carlstedt A, Sessler DI, Kouz K; IMPROVE-multi Trial Group. Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial. JAMA. 2025 Dec 2;334(21):1893-1904. doi: 10.1001/jama.2025.17235.
- Derived from this study: PubMed 36397173Bergholz A, Meidert AS, Flick M, Krause L, Vettorazzi E, Zapf A, Brunkhorst FM, Meybohm P, Zacharowski K, Zarbock A, Sessler DI, Kouz K, Saugel B. Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi). Trials. 2022 Nov 17;23(1):946. doi: 10.1186/s13063-022-06854-0.
- Individual participant dataSharing planned: Yes
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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.
Bernd Saugel, M.D. principal investigator
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized blood pressure management 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 18 inclusion and 8 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 16 Oct 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 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 outcome of major postoperative complications (time frame: Postoperative Day 7). 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 NCT05416944, which also lists 2 linked publications.
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 16 Oct 2026.