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Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery (EPITUBE-HEART)

Primary Purpose

Cardiac Disorder, Hypotension

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

noradrenaline

About this trial

This is an interventional prevention trial for Cardiac Disorder focused on measuring general anesthesia, intubation, cardiac surgery, hypotension, noradrenaline

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Requiring cardiac or thoracic surgery under general anaesthesia
Requiring a blood pressure catheter prior to GA induction

Exclusion Criteria:

Hemodynamic instability on arrival in the operating room
Hypotension on arrival in the operating theatre: Systolic blood pressure < 100 mmHg or Mean arterial pressure < 65 mmHg
Hypertension on arrival at the operating theatre: Systolic blood pressure > 160 mmHg or Mean arterial pressure > 100 mmHg
Adult under guardianship, curatorship or safeguard of justice
Unable to give consent
Pregnant or breastfeeding woman
Emergency surgery (cannot be delayed by 24 hours)
Current participation in an interventional protocol that interferes with the evaluation criteria of the study
Not affiliated to or not benefiting from a social security scheme
Lack of informed and written consent from the patient
Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
Patient with severe aortic insufficiency
Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks

Sites / Locations

Chu de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Noradrenaline

Standard care

Arm Description

Noradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation

standard care

Outcomes

Primary Outcome Measures

Intubation-related hypotension

Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3

Secondary Outcome Measures

Occurrence of complications

Occurrence (yes/no) of complications related to the intubation: Desaturation < 80%, Severe hypotension (defined as hypotension with systolic blood pressure < 80mmHg), Cardiac arrest, Death during intubation, Difficult intubation (more than two laryngoscopies and/or the use of an alternative technique after optimization of head position, with or without external laryngeal manipulation), Heart rhythm disorder (ventricular extrasystole, ventricular fibrillation, ventricular tachycardia) Esophageal intubation, Regurgitation/inhalation, Tooth breakage

Total dose of vasopressor

Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine)

Duration of episodes of hypotension

Cumulative duration of episodes of hypotension < 55mmHg

Hypotension event

At least one Mean Arterial Pressure measurement < 65 mmHg

Hypertension event

At least one Systolic Blood Pressure measurement > 160 mmHg or Mean Arterial Pressure > 100mmHg

ECC Cardiac Output

Extra Corporeal Circulation generated Cardiac Output frequency in bpm (beat per minute)

ECC Arterial Line Pressure

Extra Corporeal Circulation generated Arterial Line Pressure in mmHg

ECC Arterial Line Temperature

Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius

ECC Mean Arterial Pressure

Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg

ECC VO2

Extra Corporeal Circulation generated VO2 (Volume O2) in Liter per Minute

ECC duration

Extra Corporeal Circulation duration in minutes

ECC SaO2

Extra Corporeal Circulation generated SaO2 (Arterial Saturation in O2) in percentage

ECC SvO2

Extra Corporeal Circulation generated SvO2 (Venous Saturation in O2) in percentage

ECC PaO2

Extra Corporeal Circulation generated PaO2 (Arterial Pressure in O2) in kPa

ECC PaCO2

Extra Corporeal Circulation generated PaCO2 (Arterial Pressure in CO2) in kPa

Delirium score

At least episode with ICDSC (Intensive Care Delirium Screening Checklist) score of 4 or more (0 to 8, binary interpretation with scores from 0 to 4 excluding the presence of delirium and scores greater than or equal to 4 indicating the presence of delirium, the highest scores are not related with greater intensity of delirium)

Duration of Noradrenaline and Dobutamine treatments

Duration of treatment with Noradrenaline (in hours) and Dobutamine (in hours)

PaO2/FiO2

Lowest value of PaO2/FiO2 (Arterial Pressure of O2 / Fraction inspired in Oxygen) measured

Dialysis

Use of dialysis in intensive care (Yes/No)

Hemolysis index

Maximum hemolysis index (0 to 10000, with higher scores being more pejorative)

Acute renal failure

Occurrence of acute renal failure. This criterion will be assessed using the KDIGO (Kidney Disease: Improving Global Outcomes) scale (stage 1 to 3 with higher stages being more pejorative). Any renal attack defined as at least stage I according to this classification (1.5 to 1.9 times the base rate) will be considered as acute renal failure. The "urinary output assessment" component of the KDIGO scale will not be used because of the frequency of use of diuretics in cardiac surgery.

CVA

Occurrence of a CVA (cerebrovascular accident)

Postoperative invasive ventilation duration

Duration of postoperative invasive ventilation in hours: this duration is defined by the duration of mechanical ventilation between arrival in intensive care and extubation

Stay in intensive care duration

Length of stay in intensive care in days: this duration is evaluated between the day of arrival in intensive care and the date on which the patient is considered to have left intensive care (no longer subject to monitoring in intensive care).

Hospitalization duration

Length of hospitalization in days

Mortality

Death of the patient

Full Information

NCT ID

NCT05335954

First Posted

November 9, 2021

Last Updated

April 28, 2022

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05335954

Brief Title

Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery

Acronym

EPITUBE-HEART

Official Title

Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 27, 2022 (Actual)

Primary Completion Date

November 27, 2023 (Anticipated)

Study Completion Date

November 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation. The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low. The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Disorder, Hypotension

Keywords

general anesthesia, intubation, cardiac surgery, hypotension, noradrenaline

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Patient under anesthesia will not be aware of randomisation arm. the team collecting primary endpoint (hypotension under 55 mg during the 20 minutes after the start of anesthesia) will not be aware of patient assignation.

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Noradrenaline

Arm Type

Experimental

Arm Description

Noradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

standard care

Intervention Type

Drug

Intervention Name(s)

noradrenaline

Intervention Description

noradrenaline

Primary Outcome Measure Information:

Title

Intubation-related hypotension

Description

Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3

Time Frame

Within 20 minutes of the start of general anesthesia (induction)

Secondary Outcome Measure Information:

Title

Occurrence of complications

Description

Time Frame