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NCT Number: NCT05335954

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

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.

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Key information

Conditions

Cardiac Disorder Cardiovascular Diseases Heart Diseases Hypotension Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu de Nantes

Nantes, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Noradrenaline

Drug

noradrenaline

Primary outcomes

  1. Intubation-related hypotension

    Time frame: Within 20 minutes of the start of general anesthesia (induction)

    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 outcomes

  1. Occurrence of complications

    Time frame: Within 20 minutes of the start of the intubation

    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

  2. Total dose of vasopressor

    Time frame: Within 20 minutes of the start of the intubation

    Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine)

  3. Duration of episodes of hypotension

    Time frame: Within 20 minutes of the start of the intubation

    Cumulative duration of episodes of hypotension < 55mmHg

  4. Hypotension event

    Time frame: Within 20 minutes of the start of the intubation

    At least one Mean Arterial Pressure measurement < 65 mmHg

  5. Hypertension event

    Time frame: Within 20 minutes of the start of the intubation

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

  6. ECC Cardiac Output

    Time frame: Within 20 minutes of the start of the intubation

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

  7. ECC Arterial Line Pressure

    Time frame: Within 20 minutes of the start of the intubation

    Extra Corporeal Circulation generated Arterial Line Pressure in mmHg

  8. ECC Arterial Line Temperature

    Time frame: Within 20 minutes of the start of the intubation

    Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius

  9. ECC Mean Arterial Pressure

    Time frame: Within 20 minutes of the start of the intubation

    Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg

  10. ECC VO2

    Time frame: Within 20 minutes of the start of the intubation

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

  11. ECC duration

    Time frame: Within 20 minutes of the start of the intubation

    Extra Corporeal Circulation duration in minutes

  12. ECC SaO2

    Time frame: Within 20 minutes of the start of the intubation

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

  13. ECC SvO2

    Time frame: Within 20 minutes of the start of the intubation

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

  14. ECC PaO2

    Time frame: Within 20 minutes of the start of the intubation

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

  15. ECC PaCO2

    Time frame: Within 20 minutes of the start of the intubation

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

  16. Delirium score

    Time frame: After extubation within 48 hours postoperatively

    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)

  17. Duration of Noradrenaline and Dobutamine treatments

    Time frame: Within 28 days after surgery

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

  18. PaO2/FiO2

    Time frame: In the 5 post-operative days

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

  19. Dialysis

    Time frame: Within 28 days after surgery

    Use of dialysis in intensive care (Yes/No)

  20. Hemolysis index

    Time frame: In the 5 post-operative days

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

  21. Acute renal failure

    Time frame: In the 5 post-operative days

    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.

  22. CVA

    Time frame: In the 5 post-operative days

    Occurrence of a CVA (cerebrovascular accident)

  23. Postoperative invasive ventilation duration

    Time frame: Until 28 days after surgery

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

  24. Stay in intensive care duration

    Time frame: Until 28 days after surgery

    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).

  25. Hospitalization duration

    Time frame: Until 28 days after surgery

    Length of hospitalization in days

  26. Mortality

    Time frame: Until 28 days after surgery

    Death of the patient

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: EPITUBE-HEART

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Mar 7, 2024

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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