Clinical trial NCT05637606: HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery
Official title: HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Complication,Postoperative
Intraoperative Hypotension
Keywords: Blood pressure
Intraoperative Hypotension
Postoperative complications
Postoperative mortality
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
Collaborators: name: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
First posted: 2022-12-05
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion criteria (all the following)

1. Adult patients ≥ 60 years
2. History of chronic hypertension requiring home therapy.
3. Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)
4. Expected surgical duration of at least 3 hours.
5. 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

At increased risk of postoperative complications (at least one of the following):

1. American Society of Anesthesiologists (ASA) class 3 or 4
2. Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome).
3. Known or documented history of peripheral vascular disease.
4. Known or documented history of heart failure requiring treatment.
5. Ejection fraction less than 30% (echocardiography)
6. Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography)
7. Moderate or severe valvular heart disease (echocardiography)
8. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
9. Diabetes currently treated with an oral hypoglycemic agent and/or insulin
10. Morbid obesity (BMI ≥35 kg/m2)
11. Preoperative serum albumin \<30 g/l
12. Anaerobic threshold (if done) \<14 ml/kg/min
13. Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines

Exclusion criteria

1. Refusal of consent
2. Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
3. Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).
4. Urgent or time-critical surgery
5. Aortic or Renal vascular surgery (including nephrectomy)
6. Liver Surgery
7. Neurosurgery
8. Surgery for palliative treatment only or ASA physical status 5
9. Pregnancy

Primary outcomes:
measure: Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
timeFrame: up to 30 days after operation
Secondary outcomes:
measure: Hospital stay (days)
timeFrame: up to 30 days after operation
measure: ICU stay (days)
timeFrame: up to 30 days after operation
measure: ICU readmission
timeFrame: up to 30 days after operation
measure: Sequential Organ Failure Assessment (SOFA) scores on postoperative
timeFrame: up to 7 days after operation
measure: Overall intraoperative fluid balance
timeFrame: day 1 after the operation
measure: Mortality
timeFrame: up to 30 days after operation
measure: Vasopressors use
timeFrame: day 1 after the operation
measure: Need for reoperation
timeFrame: day 30 after operation
Other outcomes:
measure: CARDIOVASCULAR complications
timeFrame: day 7 after operation
measure: NEUROLOGICAL complications
timeFrame: day 7 after operation
measure: RESPIRATORY
timeFrame: day 7 after operation
measure: RENAL
timeFrame: day 7 after operation
measure: SEPSIS and Septic shock
timeFrame: day 7 after operation
Locations:
city: Modena
country: Italy
facility: Department of Anesthesia and Intensive Care, University Hospital of Modena
state: Emilia Romagna
city: Roma
country: Italy
facility: Policlinico A. Gemelli
state: Lazio
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
city: Foggia
country: Italy
facility: Ospedali Riuniti Foggia- Università di Foggia
state: Puglia
city: Cefalù
country: Italy
facility: Fondazione Istituto San Raffaele G. Giglio
state: Sicilia
city: Firenze
country: Italy
facility: Careggi University Hospital
state: Toscana
city: Verona
country: Italy
facility: Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona
state: Veneto
city: Alessandria
country: Italy
facility: Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Ospedale Antonio Cardarelli
city: Pordenone
country: Italy
facility: Azienda sanitaria Friuli Occidentale (AsFO]
city: Prato
country: Italy
facility: Ospedale Santo Stefano
city: Reggio Emilia
country: Italy
facility: Ospedale S. Anna di Castelnovo ne' Monti
city: Roma
country: Italy
facility: Sant'Eugenio ASL Roma 2:
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria di Sassari
city: Torino
country: Italy
facility: Ospedale Molinette
city: Trento
country: Italy
facility: Ospedale Santa Chiara di Trento
Study officials:
affiliation: Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy
name: Antonio Messina
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.