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Completed

NCT Number: NCT05637606

HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti Foggia- Università di Foggia, Foggia, Apulia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all the following)

  • 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

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

Exclusion criteria

  • 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
  • Neurosurgery
  • Surgery for palliative treatment only or ASA physical status 5
  • Pregnancy

Treatment and study plan

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

Other names: Ephedrine bolus

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.

Other names: norepinephrine infusion

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

Other names: Hemodynamic optimization

Primary outcomes

  1. 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

Secondary outcomes

  1. Hospital stay (days)

    Time frame: up to 30 days after operation

    Hospital stay (days)

  2. ICU stay (days)

    Time frame: up to 30 days after operation

    Intensive Care Unit stay (days)

  3. ICU readmission

    Time frame: up to 30 days after operation

    Intensive Care Unit readmissions

  4. Sequential Organ Failure Assessment (SOFA) scores on postoperative

    Time frame: up to 7 days after operation

    Postoperative organ failure - SOFA scores ranges from 0 (<2% of mortality) to 24 (>90% of mortality)

  5. Overall intraoperative fluid balance

    Time frame: day 1 after the operation

    Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)

  6. Mortality

    Time frame: up to 30 days after operation

    Mortality

  7. Vasopressors use

    Time frame: day 1 after the operation

    Dose and timing of vasoactive drug infusion intraoperatively

  8. Need for reoperation

    Time frame: day 30 after operation

    Need of a new surgical treatment

Other outcomes

  1. CARDIOVASCULAR complications

    Time frame: day 7 after operation

    • Acute heart failure
    • Myocardial injury after non-cardiac surgery
    • Myocardial infarction
    • Bradycardia
    • Symptomatic proximal deep venous thrombosis
    • Peripheral arterial and venous thrombosis
  2. NEUROLOGICAL complications

    Time frame: day 7 after operation

    • Stroke
    • Subarachnoid hemorrhage
    • Cerebral venous thrombosis
    • Seizure
    • Acute delirium
  3. RESPIRATORY

    Time frame: day 7 after operation

    • Acute respiratory distress
    • Hypoxemia with or without acute respiratory distress
    • Need for invasive, non-invasive ventilation or high-flow nasal cannula for acute respiratory distress.
    • Acute respiratory distress syndrome.
    • Pulmonary edema
    • Pulmonary embolism
  4. RENAL

    Time frame: day 7 after operation

    • Acute Kidney Injury (AKI) and AKI stages defined according to the AKIN classification/staging system of acute kidney injury
  5. SEPSIS and Septic shock

    Time frame: day 7 after operation

    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

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Collaborators

  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Registry information

Official study title

HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.

Acronym: HISTAP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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