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CRITICAL CARE TRIALS

Stay ahead of the curve with exciting new clinical trials from the critical care field presented in vivid, visual abstract format. Gain comprehensive and insightful perspectives as each critical development is delivered to you. 

OPTIMISE Trial

OPTIMISE Trial

Dec 18, 2024

Seven versus 14 days of antimicrobial therapy for severe multidrug-resistant Gram-negative bacterial infections in intensive care unit patients

This trial evaluated the non-inferiority of 7-day versus 14-day antimicrobial therapy for ICU-acquired severe infections caused by MDR-GNB. In the ITT population (n=106), clinical failure rates were 42.4% (7-day) and 44.7% (14-day) (RD −2.3%, 95%CI −21.3 to 16.7). The trial was underpowered due to early termination from low recruitment, leaving non-inferiority inconclusive. Respiratory tract infections were most common (68.9%), often caused by carbapenem-resistant Enterobacterales.

PEERLESS Trial

PEERLESS Trial

Oct 30, 2024

Large-bore Mechanical Thrombectomy Versus Catheter-directed Thrombolysis in the Management of Intermediate-risk Pulmonary Embolism

The PEERLESS trial compared large-bore mechanical thrombectomy (LBMT) to catheter-directed thrombolysis (CDT) in intermediate-risk PE. Among 550 patients, LBMT significantly reduced the composite primary endpoint (win ratio 5.01, 95% CI: 3.68–6.97, p<0.001) by lowering rates of clinical deterioration, ICU admissions (41.6% vs. 98.6%), and prolonged ICU stays (>24 hours: 19.3% vs. 64.5%). Mortality and major bleeding rates were similar, but LBMT improved respiratory outcomes and shortened hospital stays (4.5 vs. 5.3 days, p=0.002). These findings highlight LBMT as a superior intervention for intermediate-risk PE.

PRECISe

PRECISe

Aug 17, 2024

Effect of high versus standard protein provision on functional recovery in people with critical illness

This multicenter RCT compared high protein (2.0 g/kg/day) to standard protein (1.3 g/kg/day) provision in 935 mechanically ventilated critically ill patients. High protein was associated with worse health-related quality of life at 30, 90, and 180 days post-randomization (mean EQ-5D-5L score difference: -0.05; 95% CI -0.10 to -0.01; p=0.031). Mortality rates were similar, but gastrointestinal intolerance was higher with high protein (OR 1.76; 95% CI 1.06–2.92; p=0.030). Findings favor standard protein provision for better recovery and fewer complications

REVISE TRIAL

REVISE TRIAL

Jun 14, 2024

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

This international, blinded RCT evaluated pantoprazole (40 mg daily) versus placebo in 4821 mechanically ventilated ICU patients. Pantoprazole significantly reduced clinically important upper gastrointestinal bleeding (1.0% vs. 3.5%; HR 0.30, 95% CI 0.19–0.47, p<0.001) and patient-important bleeding (1.5% vs. 4.2%; HR 0.36, 95% CI 0.25–0.53, p<0.001). There was no effect on 90-day mortality (29.1% vs. 30.9%; HR 0.94, p=0.25). Rates of ventilator-associated pneumonia and C. difficile infection were similar. Pantoprazole effectively prevents gastrointestinal bleeding without impacting overall survival.

BLING III

BLING III

Jun 12, 2024

Continuous vs Intermittent β-Lactam Antibiotic Infusions in Critically Ill Patients With Sepsis

The BLING III trial compared continuous versus intermittent β-lactam infusions (piperacillin-tazobactam or meropenem) in 7031 critically ill sepsis patients. Continuous infusion showed no statistically significant reduction in 90-day mortality (24.9% vs. 26.8%, OR 0.91, 95% CI 0.81–1.01, p=0.08) but achieved higher clinical cure at 14 days (55.7% vs. 50.0%). Secondary outcomes, including ICU and hospital mortality, were similar. Continuous infusion may improve infection resolution, but its mortality benefit remains inconclusive. Practical considerations and resource availability should guide administration strategies

PROTECTION

PROTECTION

Jun 12, 2024

A Randomized Trial of Intravenous Amino Acids for Kidney Protection

This multicenter RCT evaluated intravenous amino acid infusion versus placebo in 3511 adults undergoing cardiac surgery with cardiopulmonary bypass. Amino acids reduced AKI incidence per KDIGO criteria (26.9% vs. 31.7%; RR 0.85, 95% CI 0.77–0.94, p=0.002) and Stage 3 AKI (1.6% vs. 3.0%; RR 0.56, 95% CI 0.35–0.87). Kidney-replacement therapy use was slightly lower (1.4% vs. 1.9%). Secondary outcomes and adverse events showed no significant differences. Findings suggest amino acids may reduce AKI risk in this high-risk population but have limited impact on broader outcomes.

REGARD-VAP

REGARD-VAP

Jan 22, 2024

Individualized, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia.

This phase 4, open-label trial evaluated short-course (≤7 days) versus usual care (≥8 days) antibiotics in 461 adults with ventilator-associated pneumonia (VAP). The 60-day composite outcome of death or pneumonia recurrence was similar between groups (41% vs. 44%), confirming non-inferiority. Antibiotic side effects were significantly lower in the short-course group (8% vs. 38%). Median antibiotic duration was 6 days (IQR 5–7) in the short-course group versus 14 days (IQR 10–21) in usual care. Findings support short-course antibiotic therapy as safe and effective for VAP.

The NICO Trial

The NICO Trial

Nov 29, 2023

Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning

This study evaluated conservative airway management versus routine tracheal intubation in 225 comatose patients (GCS <9) with suspected acute poisoning. No in-hospital deaths occurred in either group. The conservative strategy showed clinical benefit (win ratio 1.85, 95% CI 1.33–2.58) with fewer adverse events (6% vs. 14.7%, absolute risk difference 8.6%) and pneumonia cases (6.9% vs. 14.7%, absolute risk difference −7.8%). These findings suggest withholding intubation may improve outcomes in select patients without increasing mortality risk.

The MINT Trial

The MINT Trial

Nov 11, 2023

Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia

This RCT evaluated liberal (Hb <10 g/dL) versus restrictive (Hb <7–8 g/dL) transfusion strategies in 3504 patients with myocardial infarction and anemia (Hb <10 g/dL). The primary outcome (MI or death at 30 days) was similar (16.9% vs. 14.5%; RR 1.15, 95% CI 0.99–1.34, p=0.07). Mortality (9.9% vs. 8.3%) and MI rates (8.5% vs. 7.2%) trended higher in the restrictive group. Findings suggest no significant benefit of liberal transfusion but highlight potential risks of restrictive strategies. Tailored transfusion thresholds are recommended for this high-risk population

AMIKINHAL Trial

AMIKINHAL Trial

Oct 25, 2023

Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia

This multicenter RCT assessed inhaled amikacin (20 mg/kg daily for 3 days) versus placebo in 847 mechanically ventilated adults (>72 hours). Inhaled amikacin significantly reduced ventilator-associated pneumonia incidence (15% vs. 22%; p=0.004) and infection-related complications. Adverse effects were slightly higher in the amikacin group but not significantly so. Findings suggest inhaled amikacin as a preventive measure in critically ill ventilated patients, though benefits must be weighed against potential risks. Longer-term outcomes require further study.

The ACRON Trial

The ACRON Trial

Oct 14, 2023

Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized with Acute Infection

This study compared Cefepime and Piperacillin-Tazobactam in 2511 hospitalized adults requiring antipseudomonal antibiotics. Rates of stage 3 acute kidney injury (7.0% vs. 7.5%) and mortality (7.6% vs. 6.0%) were similar between groups. However, patients on Cefepime had more neurological dysfunction, with fewer days alive and free of delirium or coma (11.9 vs. 12.2 days). Findings suggest equivalent kidney injury and mortality risks but highlight Cefepime’s association with increased neurotoxicity, guiding antibiotic selection in critically ill patients.

ECLS-SHOCK

ECLS-SHOCK

Aug 26, 2023

Extracorporeal Life Support in Infarct-Related Cardiogenic Shock

This multicenter RCT evaluated early extracorporeal life support (ECLS) plus usual care versus usual care alone in 417 patients with acute myocardial infarction complicated by cardiogenic shock. At 30 days, mortality was similar (47.8% vs. 49.0%; RR 0.98, 95% CI 0.80–1.19, p=0.81). ECLS increased mechanical ventilation duration (median 7 vs. 5 days), bleeding (23.4% vs. 9.6%; RR 2.44), and vascular complications (11.0% vs. 3.8%; RR 2.86). The study suggests that early routine ECLS does not improve survival and may increase complications, requiring careful patient selection.

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