Intraoperative Noradrenaline to Control Arterial Pressure (INPRESS Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Aguettant laboratory
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01536470
First received: February 13, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Control of Arterial Blood Pressure
Other: noradrenaline
Other: Ephedryne chorydrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Noradrenaline to Control Intraoperative Arterial Pressure in High-risk Surgical Patients: A Multicentre Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Composite endpoint of postoperative SIRS and at least one major organ dysfunction [ Time Frame: day-7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of intraoperative hypotension [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Incidence of intraoperative hypertension [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Incidence of intraoperative bradycardia [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Intraoperative volume of fluid perfused [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Intraoperative blood losses [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Need for intraoperative transfusion [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Postoperative organ failure [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]
  • Biologic criteria: plasma concentration of NGAL, creatinine, CRP, serum lactate, troponine) [ Time Frame: at day 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Noradrenaline
Continuous infusion of noradrenaline to maintain arterial blood pressure management in high-risk surgical patients
Other: noradrenaline
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.
Experimental: Ephedrine chorhydrate
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
Other: Ephedryne chorydrate

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536470

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Aguettant laboratory
Investigators
Principal Investigator: Emmanuel FUTIER University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01536470     History of Changes
Other Study ID Numbers: CHU-0111, 2011-004232-66
Study First Received: February 13, 2012
Last Updated: December 7, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Intraoperative hemodynamic
Arterial pressure
Postoperative complications
Intraoperative fluids
Noradrenaline

Additional relevant MeSH terms:
Ephedrine
Norepinephrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on July 22, 2014