Respiratory, hemodynamic and inflammatory effects of induced HypothermiA using NoVAtherm with extra corporeal membrane ventilator iLA-Activve in patients with acute respiratory distress syndrome (ARDS)

Respiratory, hemodynamic and inflammatory effects of induced HypothermiA using NoVAtherm with extra corporeal membrane ventilator iLA-Activve in patients with acute respiratory distress syndrome (ARDS) - HAVAnA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39735

Enrollment

Registered

2012-12-06

Start date

2013-07-03

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Interventions

Randomized controlled open label trial in mechanically ventilated patients, admitted at the Intensive Care Unit with ARDS. Patients will be randomized to one of the following groups: 1) Use of iLA-

2) Use of iLA-Activve MinilungTM while maintaining normotemperature during 12 hours

3) Standard care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Suffering of a clinical condition associated with ARDS 2) ARDS according to the Berlin definition (P/F 5 cmH2O; bilateral pulmonary opacities at chest X-ray; respiratory failure not fully explained by cardiac failure or volume overload) 3) Mechanical ventilation with maximum inspiratory pressure levels (Pmax) of > 30 cm H2O, while maintaining tidal volume ventilation of 6-8 ml/kg ideal body weight and permissive hypercapnia with an arterial pH

Exclusion criteria

Exclusion criteria: 1) Contra-indication for (low dose of) heparin 2) Severe shock, requiring norepinephrin dose of > 2 mg/hour 3) Severe hypoxia, requiring referral for extra corporeal membrane oxygenation

Design outcomes

Primary

Measure	Time frame
Minute volume ventilation	—

Secondary

Measure	Time frame
Hemodynamic parameters: intra-arterial systolic and diastolic pressure, cardiac output, right and left ventricular contractile function, parameters of pre-load and after-load and pulmonary arterial pressures Ventilatory parameters: Pmax, CVD, ScvO2, PaO2, PvO2, (A-a) difference, PCO2, etCO2, tidal volumes, respiratory rate, PEEP level, pressure volume curves, compliance, work of breathing, lung injury score. Outcome: duration of mechanical ventilation, time to ventilation-free days, length of ICU and hospital stay and 28 day mortality. Inflammatory parameters: BALF/plasma albumin ratio, BALF and plasma levels of IL-8, TNF, IL-1, IL-6, IL-10, EA complexes, D-dimers, thrombin-antithrombin complex, PAI-1, PAA% (by ELISA). Metabolic parameters: VO2, VCO2, EE, mitochondrial respiration, mitochondrial enzymes and mitochondrial DNA (isolated from circulating platelets).	—

Measure

Time frame

Hemodynamic parameters: intra-arterial systolic and diastolic pressure, cardiac output, right and left ventricular contractile function, parameters of pre-load and after-load and pulmonary arterial pressures Ventilatory parameters: Pmax, CVD, ScvO2, PaO2, PvO2, (A-a) difference, PCO2, etCO2, tidal volumes, respiratory rate, PEEP level, pressure volume curves, compliance, work of breathing, lung injury score. Outcome: duration of mechanical ventilation, time to ventilation-free days, length of ICU and hospital stay and 28 day mortality. Inflammatory parameters: BALF/plasma albumin ratio, BALF and plasma levels of IL-8, TNF, IL-1, IL-6, IL-10, EA complexes, D-dimers, thrombin-antithrombin complex, PAI-1, PAA% (by ELISA). Metabolic parameters: VO2, VCO2, EE, mitochondrial respiration, mitochondrial enzymes and mitochondrial DNA (isolated from circulating platelets).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)