Infusion of Prostacyclin Vs Placebo for 72-hours in Mechanically Ventilated Patients with Acute Respiratory Failure

Launched by PÄR JOHANSSON · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called iloprost in patients who are on a ventilator due to severe breathing problems caused by infections. The researchers want to see if giving iloprost continuously for 72 hours can help improve the health of the blood vessels in these patients, which may lead to better recovery and survival rates. They will compare the results of those receiving iloprost to those getting a placebo (a substance with no active medicine) to find out if iloprost is effective.

To be eligible for this trial, participants must be adults aged 18 and older who are in intensive care with a suspected lung infection and need mechanical ventilation within 24 hours of being screened. They also need to have certain markers in their blood. However, individuals who are pregnant, have severe heart conditions, or have recently participated in similar studies would not be eligible. If someone joins the trial, they can expect to receive either the medication or the placebo while being closely monitored by medical staff for any effects or side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult intensive care patients (age ≥ 18 years)
• • Suspected pulmonary infection
• • Need for mechanical ventilation (\< 24 hours from time of screening)
• • soluble thrombomodulin (sTM) ≥ 4 ng/mL in blood plasma
• Exclusion Criteria:
• • Withdrawal from active therapy
• • Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma Choriogonadotropin (hCG) or being postmenopausal defined as females at 60 years old or beyond or at the investigators discretion)
• • Septic shock according to the Sepsis 3 criteria AND a sTM\> 10 ng/ml
• • Known hypersensitivity to iloprost or to any of the other ingredients.
• • Previously included in this trial or a prostacyclin trial within 30 days
• • Life-threatening bleeding defined by the treating physician
• • Known severe heart failure (NYHA class IV)
• • Suspected acute coronary syndrome