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Intraoperative Noradrenaline to Control Arterial Pressure (INPRESS Study)

Effectiveness of Noradrenaline to Control Intraoperative Arterial Pressure in High-risk Surgical Patients: A Multicentre Prospective Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01536470
Acronym
INPRESS
Enrollment
300
Registered
2012-02-22
Start date
2012-03-31
Completion date
2016-07-31
Last updated
2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Control of Arterial Blood Pressure

Keywords

Intraoperative hemodynamic, Arterial pressure, Postoperative complications, Intraoperative fluids, Noradrenaline

Brief summary

The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure.

Detailed description

The maintenance of arterial blood pressure is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery, but optimal strategy of intraoperative blood pressure management remains undetermined, especially in high-risk patients. Target ranges for arterial pressure are not clearly defined, and hypotension is usually defined as a systolic pressure of less than 80 mmHg or a decrease of more than 40% from baseline. Traditionally, management of intraoperative hypotension consisted primarily of fluid administration whereas vasoconstrictors, such as Ephedrine chlorhydrate, are often used as a second line therapy. This may, however, expose patients to prolonged hypotension and to excessive fluid administration, and each of them may alter tissue oxygenation. Recent experimental data have shown that noradrenaline, which has - and -adrenergic effects, has no detrimental effects on microcirculatory blood flow and tissue oxygenation in the intestinal tract. Because of anaesthesia-induced vasodilatation, the use of a continuous infusion of noradrenaline to increase systemic vascular resistance could be useful to prevent detrimental effects of compromised tissue perfusion, especially in high-risk surgical patients. The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate. The investigators hypothesis is that maintenance of arterial blood pressure with noradrenaline could reduce postoperative organ dysfunction in high-risk surgical patients.

Interventions

The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.

OTHEREphedryne chorydrate

Sponsors

Aguettant laboratory
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 50 years * ASA score ≥ 2 * Planned and unplanned surgical procedures * Abdominal, orthopaedic and vascular surgery * Expected duration ≥ 2 hours * AKI risk index ≥ class 3

Exclusion criteria

* Severe preoperative hypertension (not controlled) * Creatinine clearance \< 30 ml/min or preoperative dialysis * Acute cardiac failure * Preoperative sepsis * Preoperative hemodynamic failure (shock) * Intraoperative use of locoregional anaesthesia (epidural and spinal) * Patient refusal * Pregnancy and/or lactation

Design outcomes

Primary

MeasureTime frame
Composite endpoint of postoperative SIRS and at least one major organ dysfunctionday-7

Secondary

MeasureTime frame
Incidence of intraoperative hypertensionat day 7
Incidence of intraoperative bradycardiaat day 7
Intraoperative volume of fluid perfusedat day 7
Incidence of intraoperative hypotensionat day 7
Need for intraoperative transfusionat day 7
Postoperative organ failureat day 7
Biologic criteria: plasma concentration of NGAL, creatinine, CRP, serum lactate, troponine)at day 7
Intraoperative blood lossesat day 7

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026