The BigBIC-Study Carbon dioxide partial pressure (pCO2) adapted continuous hemodialysis in lung-protective ventilated ARDS patients with renal failure requiring dialysis
Phase 3
- Conditions
- J80Adult respiratory distress syndrome
- Registration Number
- DRKS00026177
- Lead Sponsor
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Males or females aged >18 years,
ARDS (any cause) defined by Berlin Definition (modified, no time restriction),
CRRT with citrate anticoagulation,
Invasive mechanical ventilation aimimg lung protective ventilation
Hypercapnia defined as pCO2 > 55mmHg with tidals >4 ml/kg and respiratory rate =12/min
Exclusion Criteria
ECMO, TRIS-buffering, Lactic acidosis > 80mg/dl, Liver failure (Bili > 8 and Quick < 50)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bicarbonate concentration 72hours after study inclusion in both groups.
- Secondary Outcome Measures
Name Time Method Efficacy: Kinetics of HCO-concentrations measures every 12 hours in both groups.<br><br>Safety: differences of adverse events in both groups during the time of intervention of 6 days: <br>-Mortality<br>-Severe acidosis (pH< 7,15)<br>-Severe alkalosis (pH >7,55)<br>-hypernatremia (>155mmol/l)<br>-severe hypo/hypercalcemia (iCa2+ <0,8 mmol/l or >1,5 mmol/l)<br>-severe hypo/hyperkalemia (<2,5mmol/l >6,5mmol/l)<br>-severe hypophosphatemia (<0,3mmol/l)<br>-Filterclotting<br>-Citrataccumulation<br><br>Median of the following parameters over the intervention period of 6 days: <br>-pH<br>-tidal volumes<br>-driving-pressure<br>-peak pressure<br>-respiratory minute volume<br><br>and<br>-catecholamine dose (max daily day 1-6) <br>-duration of mechanical ventilation (days) <br>-mortality (30 days or until ICU-discharge <br>-SOFA-score (day 1-6) <br>-blood-to-dialysate-ratio <br>