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| Name | Class |
|---|---|
| Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ephedrine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes). | Composite postoperative outcome | up to 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay (days) | Hospital stay (days) | up to 30 days after operation |
| ICU stay (days) | Intensive Care Unit stay (days) | up to 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| CARDIOVASCULAR complications |
| day 7 after operation |
| NEUROLOGICAL complications |
Inclusion criteria (all the following)
AND
At increased risk of postoperative complications (at least one of the following):
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Messina | Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti Foggia- Università di Foggia | Foggia | Apulia | Italy | |||
| Department of Anesthesia and Intensive Care, University Hospital of Modena |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33522953 | Background | 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. | |
| 23835589 |
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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:
Age ≥ 75 years
Preoperative systolic pressure
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The trial intervention is not blinded for investigators, clinical staff, and patients, as blinding intraoperative MAP target is not feasible. The physicians of each center assessing all postoperative outcomes will be masked for the allocation.
|
| Norepinephrine | Drug | 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 bolus | Drug | 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 | 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 |
|
|
| ICU readmission | Intensive Care Unit readmissions | 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) | up to 7 days after operation |
| Overall intraoperative fluid balance | Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output) | day 1 after the operation |
| Mortality | Mortality | up to 30 days after operation |
| Vasopressors use | Dose and timing of vasoactive drug infusion intraoperatively | day 1 after the operation |
| Need for reoperation | Need of a new surgical treatment | day 30 after operation |
|
| day 7 after operation |
| RESPIRATORY |
| day 7 after operation |
| RENAL | • Acute Kidney Injury (AKI) and AKI stages defined according to the AKIN classification/staging system of acute kidney injury | day 7 after operation |
| SEPSIS and Septic shock | Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis required a quick Sequential Organ Failure Assessment (qSOFA) Score ≥ 2 points due to infection, septic shock defined as indicated by the Surviving Sepsis Campaign Guidelines | day 7 after operation |
| Modena |
| Emilia-Romagna |
| Italy |
| Policlinico A. Gemelli | Rome | Lazio | Italy |
| Humanitas Research Hospital | Rozzano | MILANO | 20089 | Italy |
| Fondazione Istituto San Raffaele G. Giglio | Cefalù | Sicily | Italy |
| Careggi University Hospital | Florence | Tuscany | 50134 | Italy |
| Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona | Verona | Veneto | Italy |
| Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy |
| Istituto Nazionale dei Tumori | Milan | Italy |
| Ospedale Antonio Cardarelli | Naples | Italy |
| Azienda sanitaria Friuli Occidentale (AsFO] | Pordenone | Italy |
| Ospedale Santo Stefano | Prato | Italy |
| Ospedale S. Anna di Castelnovo ne' Monti | Reggio Emilia | Italy |
| Sant'Eugenio ASL Roma 2: | Roma | Italy |
| Azienda Ospedaliero Universitaria di Sassari | Sassari | Italy |
| Ospedale Molinette | Torino | Italy |
| Ospedale Santa Chiara di Trento | Trento | Italy |
| Background |
| Walsh 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. |
| 42370999 | Derived | Cecconi 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 Jun 29. doi: 10.1007/s00134-026-08501-7. Online ahead of print. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004809 | Ephedrine |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004983 | Ethanolamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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