Blood PressureHISTAPNCT05637606
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery
A study testing Ephedrine, Norepinephrine and Etilefrine Hydrochloride bolus in people with Blood Pressure and Complication,Postoperative, run by Humanitas Clinical and Research Center at 18 sites in Italy.
Trial summary
This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Complication,Postoperative, Intraoperative Hypotension
- What is being tested?
- Ephedrine, Norepinephrine and Etilefrine Hydrochloride bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 18 sitesItaly
- Study dates
- 6 Mar 2023to 21 May 2025
- 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
- Adult patients ≥ 60 years
- History of chronic hypertension requiring home therapy.
- Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)
- Expected surgical duration of at least 3 hours.
- Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center.
- AND
Show all 20Show fewer
- At increased risk of postoperative complications (at least one of the following):
- American Society of Anesthesiologists (ASA) class 3 or 4
- Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome).
- Known or documented history of peripheral vascular disease.
- Known or documented history of heart failure requiring treatment.
- Ejection fraction less than 30% (echocardiography)
- Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography)
- Moderate or severe valvular heart disease (echocardiography)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
- Diabetes currently treated with an oral hypoglycemic agent and/or insulin
- Morbid obesity (BMI ≥35 kg/m2)
- Preoperative serum albumin <30 g/l
- Anaerobic threshold (if done) <14 ml/kg/min
- Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines
Who cannot join
- Refusal of consent
- Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
- Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).
- Urgent or time-critical surgery
- Aortic or Renal vascular surgery (including nephrectomy)
- Liver Surgery
Show all 9Show fewer
- Neurosurgery
- Surgery for palliative treatment only or ASA physical status 5
- Pregnancy
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Fondazione Istituto San Raffaele G. Giglio
Cefalù, Sicily
Careggi University Hospital
Florence, Tuscany, 50134
Ospedali Riuniti Foggia- Università di Foggia
Foggia, Apulia
ASST Grande Ospedale Metropolitano Niguarda
Milan
Istituto Nazionale dei Tumori
Milan
Department of Anesthesia and Intensive Care, University Hospital of Modena
Modena, Emilia-Romagna
Ospedale Antonio Cardarelli
Naples
Azienda sanitaria Friuli Occidentale (AsFO]
Pordenone
Ospedale Santo Stefano
Prato
Ospedale S. Anna di Castelnovo ne' Monti
Reggio Emilia
Sant'Eugenio ASL Roma 2:
Roma
Policlinico A. Gemelli
Rome, Lazio
Humanitas Research Hospital
Rozzano, MILANO, 20089
Azienda Ospedaliero Universitaria di Sassari
Sassari
Ospedale Molinette
Torino
Ospedale Santa Chiara di Trento
Trento
Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona
Verona, Veneto
About this study
Official title: HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.
This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.
Read the detailed description
Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications.
The objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery.
The primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery.
- Being tested
- Ephedrine, Norepinephrine, Etilefrine Hydrochloride bolus, Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)
- Keywords
- Blood pressure, Intraoperative Hypotension, Postoperative complications, Postoperative mortality
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Ephedrine bolus
In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started
NorepinephrineDrug
Also called norepinephrine infusion
In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target.
Etilefrine Hydrochloride bolusDrug
The maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started
Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)Diagnostic test
Also called Hemodynamic optimization
PPV, SVV and mini_FC will guide fluid bolus administration during an episode of intraoperative hypotension, following two predefined algorithms for laparotomic/non laparotomic surgery
| Study group | Role | What they receive |
|---|---|---|
| MAP 80 | Experimental | Intervention group: intraoperative mean blood pressure target > 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values. Receives: Drug: Ephedrine; Drug: Norepinephrine; Drug: Etilefrine Hydrochloride bolus; Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC) |
| MAP 65 | Other | Control group: intraoperative mean blood pressure target > 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values. Receives: Drug: Ephedrine; Drug: Norepinephrine; Drug: Etilefrine Hydrochloride bolus; Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
Composite postoperative outcome
Measured: up to 30 days after operation
Secondary outcomes (8)
Hospital stay (days)
Hospital stay (days)
Measured: up to 30 days after operation
ICU stay (days)
Intensive Care Unit stay (days)
Measured: up to 30 days after operation
ICU readmission
Intensive Care Unit readmissions
Measured: up to 30 days after operation
Sequential Organ Failure Assessment (SOFA) scores on postoperative
Postoperative organ failure - SOFA scores ranges from 0 (<2% of mortality) to 24 (>90% of mortality)
Measured: up to 7 days after operation
Overall intraoperative fluid balance
Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)
Measured: day 1 after the operation
Mortality
Mortality
Measured: up to 30 days after operation
Vasopressors use
Dose and timing of vasoactive drug infusion intraoperatively
Measured: day 1 after the operation
Need for reoperation
Need of a new surgical treatment
Measured: day 30 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start6 Mar 2023
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- The study will be a multicentric, randomized, non-blinded clinical trial. Eligible patients will be assigned in a 1:1 ratio to either a to control or treatment group. Randomization list will be created by a computer with the use of a permuted block design and embedded in the Electronic Case Report Form. Randomization will be performed using a 'block of 6" and stratified according to predefined baseline characteristics: 1. Age ≥ 75 years 2. Preoperative systolic pressure 1. \< 140 mmHg 2. ≥ 140 mmHg
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Responsible party
- Principal investigator, Antonio Messina, Humanitas Clinical and Research Center
- Investigators
- Antonio Messina, Principal investigator, Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637606
- Sponsor's protocol ID
- HISTAP TRIAL
- Acronym
- HISTAP
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.
PubMed 33522953Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Cecconi M, Cortegiani A, Noto A, Sotgiu G, Antonelli M, Anderloni M, Barbaresco I, Bizzarri F, Brunati A, Cappellini I, Cammarota G, Caporale M, Collino F, Cuschera M, Coloretti I, Donadello K, Foti L, Frassanito L, Fiume D, Girardis M, L'Acqua C, Lauro G, Maggiore SM, Magnoni S, Mirabella L, Misseri G, Miori S, Matronola GM, Pavan G, Pellis T, Piccioni F, Puci MV, Pugliese S, Romano B, Russo A, Samuelli N, Torrano V, Viani A, Jaber S, Azoulay E, Romagnoli S, Messina A; SIAARTI Study Group. HIgh versus STAndard blood Pressure target in hypertensive high-risk patients undergoing elective major abdominal surgery: the HISTAP multicenter randomized clinical trial. Intensive Care Med. 2026 Aug;52(8):1619-1634. doi: 10.1007/s00134-026-08501-7. Epub 2026 Jun 29.
PubMed 42370999
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05637606
- Acronym / sponsor ID
- HISTAP / HISTAP TRIAL
- Keywords
- Blood pressure, Intraoperative Hypotension, Postoperative complications, Postoperative mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Collaborators
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 5 Dec 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.
This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.
Detailed description
Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications.
The objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery.
The primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a multicentric, randomized, non-blinded clinical trial. Eligible patients will be assigned in a 1:1 ratio to either a to control or treatment group. Randomization list will be created by a computer with the use of a permuted block design and embedded in the Electronic Case Report Form. Randomization will be performed using a 'block of 6" and stratified according to predefined baseline characteristics: 1. Age ≥ 75 years 2. Preoperative systolic pressure 1. < 140 mmHg 2. ≥ 140 mmHg
| Arm | Type | Receives |
|---|---|---|
| MAP 80 | Experimental | Drug: Ephedrine, Drug: Norepinephrine, Drug: Etilefrine Hydrochloride bolus, Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)Intervention group: intraoperative mean blood pressure target > 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values. |
| MAP 65 | Other | Drug: Ephedrine, Drug: Norepinephrine, Drug: Etilefrine Hydrochloride bolus, Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)Control group: intraoperative mean blood pressure target > 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult patients ≥ 60 years
- History of chronic hypertension requiring home therapy.
- Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)
- Expected surgical duration of at least 3 hours.
- Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center.
Key exclusion criteria (9 listed)
- Refusal of consent
- Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
- Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).
- Urgent or time-critical surgery
- Aortic or Renal vascular surgery (including nephrectomy)
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 |
|---|---|---|
| EphedrineAlso: Ephedrine bolusIn both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started | Drug | MAP 65, MAP 80 |
| NorepinephrineAlso: norepinephrine infusionIn both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target. | Drug | MAP 65, MAP 80 |
| Etilefrine Hydrochloride bolusThe maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started | Drug | MAP 65, MAP 80 |
| Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)Also: Hemodynamic optimizationPPV, SVV and mini_FC will guide fluid bolus administration during an episode of intraoperative hypotension, following two predefined algorithms for laparotomic/non laparotomic surgery | Diagnostic test | MAP 65, MAP 80 |
Primary outcome
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
Time frame: up to 30 days after operation
Composite postoperative outcome
8 secondary outcomes
Hospital stay (days)
Time frame: up to 30 days after operation
ICU stay (days)
Time frame: up to 30 days after operation
ICU readmission
Time frame: up to 30 days after operation
Sequential Organ Failure Assessment (SOFA) scores on postoperative
Time frame: up to 7 days after operation
Overall intraoperative fluid balance
Time frame: day 1 after the operation
Mortality
Time frame: up to 30 days after operation
Vasopressors use
Time frame: day 1 after the operation
Need for reoperation
Time frame: day 30 after operation
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 11 Jun 2025.
- Background: PubMed 33522953Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Derived from this study: PubMed 42370999Cecconi M, Cortegiani A, Noto A, Sotgiu G, Antonelli M, Anderloni M, Barbaresco I, Bizzarri F, Brunati A, Cappellini I, Cammarota G, Caporale M, Collino F, Cuschera M, Coloretti I, Donadello K, Foti L, Frassanito L, Fiume D, Girardis M, L'Acqua C, Lauro G, Maggiore SM, Magnoni S, Mirabella L, Misseri G, Miori S, Matronola GM, Pavan G, Pellis T, Piccioni F, Puci MV, Pugliese S, Romano B, Russo A, Samuelli N, Torrano V, Viani A, Jaber S, Azoulay E, Romagnoli S, Messina A; SIAARTI Study Group. HIgh versus STAndard blood Pressure target in hypertensive high-risk patients undergoing elective major abdominal surgery: the HISTAP multicenter randomized clinical trial. Intensive Care Med. 2026 Aug;52(8):1619-1634. doi: 10.1007/s00134-026-08501-7. Epub 2026 Jun 29.
- 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.
Antonio Messina principal investigator
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ephedrine, Norepinephrine and Etilefrine Hydrochloride bolus in people with Blood Pressure and Complication,Postoperative, run by Humanitas Clinical and Research Center at 18 sites in Italy.
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 20 inclusion and 9 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. 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 of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes). (time frame: up to 30 days after operation). 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 NCT05637606, which also lists 3 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 11 Jun 2025.