NCT01536470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

February 13, 2012

Last Update Submit

September 30, 2016

Conditions

Control of Arterial Blood Pressure

Keywords

Intraoperative hemodynamicArterial pressurePostoperative complicationsIntraoperative fluidsNoradrenaline

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of postoperative SIRS and at least one major organ dysfunction

    day-7

Secondary Outcomes (8)

  • Incidence of intraoperative hypotension

    at day 7

  • Incidence of intraoperative hypertension

    at day 7

  • Incidence of intraoperative bradycardia

    at day 7

  • Intraoperative volume of fluid perfused

    at day 7

  • Intraoperative blood losses

    at day 7

  • +3 more secondary outcomes

Study Arms (2)

Noradrenaline

EXPERIMENTAL

Continuous infusion of noradrenaline to maintain arterial blood pressure management in high-risk surgical patients

Other: noradrenaline

Ephedrine chorhydrate

EXPERIMENTAL

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

Interventions

noradrenalineOTHER

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.

Noradrenaline
Ephedryne chorydrateOTHER
Ephedrine chorhydrate

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

    PMID: 28973220DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Emmanuel FUTIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 22, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

FR(1)