Ulcer Prophylaxis during Mechanical Ventilation | NEJM

Summary

A multinational, randomized, blinded, placebo-controlled trial involving 4821 critically ill adults on invasive mechanical ventilation in the ICU found that pantoprazole reduced the risk of clinically important upper gastrointestinal bleeding to 1% compared to 3.5% in the placebo group. However, this acid suppression treatment did not decrease the 90-day mortality rate, which was about 30% in both groups. The study suggests pantoprazole's effectiveness in preventing bleeding without affecting overall survival rates.

Takeaways

• 🚑 Critically ill patients in the ICU are at a higher risk of stress-induced gastrointestinal ulcers that may lead to significant bleeding.
• 💊 Proton-pump inhibitors (PPIs) like pantoprazole are commonly used to mitigate this risk, despite some studies suggesting a potential increase in mortality with PPI treatment.
• 🔬 A new multinational, randomized, blinded, placebo-controlled trial was conducted to examine the effects of pantoprazole in critically ill patients.
• 🏥 The study involved 4821 critically ill adults on invasive mechanical ventilation in the ICU, who were given either pantoprazole or a placebo.
• 🔑 The dosage of pantoprazole was 40 mg per day, administered as an infusion, and the treatment lasted up to 90 days or until the end of ventilation.
• 📉 The primary efficacy outcome showed a significant reduction in upper gastrointestinal bleeding in the pantoprazole group compared to the placebo group (1% vs. 3.5%).
• 🔄 Secondary outcomes, such as ventilator-associated pneumonia and Clostridioides difficile infection, were similar between the two groups.
• 💔 The primary safety outcome, which was death from any cause within 90 days, occurred in about 30% of patients in both the pantoprazole and placebo groups.
• 📉 The use of pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding in critically ill patients.
• ⏳ There was no difference in the risk of death during the 90-day follow-up period between the pantoprazole and placebo groups.
• 📚 Full trial results are available for further review at NEJM.org, providing detailed insights into the study's methodology and findings.

Q & A

What is the risk associated with critically ill patients in the intensive care unit?

Critically ill patients in the intensive care unit have an increased risk of stress-induced gastrointestinal ulcers, which can lead to clinically important bleeding.

What is the usual treatment to reduce the risk of gastrointestinal ulcers in ICU patients?

Acid suppression with proton-pump inhibitors, such as pantoprazole, is commonly used to reduce the risk of gastrointestinal ulcers in ICU patients.

What concerns have been raised about the use of proton-pump inhibitors in critically ill patients?

Some studies have shown an increased mortality rate among patients with severe illness who are treated with proton-pump inhibitors.

What was the aim of the new trial mentioned in the script?

The new trial aimed to examine the effects of pantoprazole in critically ill adult patients undergoing invasive mechanical ventilation in the ICU.

How was the trial designed to ensure unbiased results?

The trial was a multinational, randomized, blinded, placebo-controlled study to ensure unbiased results.

How many patients were included in the trial, and what was the duration of treatment?

The trial included 4821 critically ill adults, and they were assigned to receive infusions of either pantoprazole or placebo daily for up to 90 days or until the end of mechanical ventilation.

What was the primary efficacy outcome measured in the trial?

The primary efficacy outcome was the occurrence of clinically important upper gastrointestinal bleeding.

What were the results regarding the primary efficacy outcome in the pantoprazole group compared to the placebo group?

The primary efficacy outcome was significantly less common in the pantoprazole group (1%) than in the placebo group (3.5%).

What were the secondary-outcome events considered in the trial?

The secondary-outcome events included ventilator-associated pneumonia and Clostridioides difficile infection.

Were there any differences in the risks of secondary-outcome events between the two groups?

The risks of secondary-outcome events were similar in both the pantoprazole and placebo groups.

What was the primary safety outcome of the trial, and what were the results?

The primary safety outcome was death from any cause at 90 days, which occurred in approximately 30% of the patients in both groups.

What conclusion did the authors draw from the trial results?

The authors concluded that pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding in critically ill patients undergoing invasive mechanical ventilation, but it did not lower the risk of death during the 90-day follow-up.

Where can the full trial results be found?

The full trial results are available at NEJM.org.