The BigBIC-Study Carbon dioxide partial pressure (pCO2) adapted continuous hemodialysis in lung-protective ventilated ARDS patients with renal failure requiring dialysis

The BigBIC-Study Carbon dioxide partial pressure (pCO2) adapted continuous hemodialysis in lung-protective ventilated ARDS patients with renal failure requiring dialysis - BigBIC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026177

Enrollment

Registered

2021-09-09

Start date

2021-09-21

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J80

Interventions

Group 1: Intervention group: Standard of care and target HCO3 to ((pCO2-45mmHg)/10mmHg)*4mmol/l + 24mmol/l, Intervention for 6 days. Filter exchange every 72 hours. Group 2: Control group: Standard tr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: ECMO, TRIS-buffering, Lactic acidosis > 80mg/dl, Liver failure (Bili > 8 and Quick < 50)

Design outcomes

Primary

Measure	Time frame
Bicarbonate concentration 72hours after study inclusion in both groups.	—

Secondary

Measure	Time frame
Efficacy: Kinetics of HCO-concentrations measures every 12 hours in both groups. Safety: differences of adverse events in both groups during the time of intervention of 6 days: - Mortality - Severe acidosis (pH7,55) - hypernatremia (>155mmol/l) - severe hypo/hypercalcemia (iCa2+ 1,5 mmol/l) - severe hypo/hyperkalemia (6,5mmol/l) - severe hypophosphatemia (<0,3mmol/l) - Filterclotting - Citrataccumulation Median of the following parameters over the intervention period of 6 days: -pH -tidal volumes -driving-pressure -peak pressure -respiratory minute volume and -catecholamine dose (max daily day 1-6) -duration of mechanical ventilation (days) -mortality (30 days or until ICU-discharge -SOFA-score (day 1-6) -blood-to-dialysate-ratio	—

Measure

Time frame

Efficacy: Kinetics of HCO-concentrations measures every 12 hours in both groups. Safety: differences of adverse events in both groups during the time of intervention of 6 days: - Mortality - Severe acidosis (pH7,55) - hypernatremia (>155mmol/l) - severe hypo/hypercalcemia (iCa2+ 1,5 mmol/l) - severe hypo/hyperkalemia (6,5mmol/l) - severe hypophosphatemia (<0,3mmol/l) - Filterclotting - Citrataccumulation Median of the following parameters over the intervention period of 6 days: -pH -tidal volumes -driving-pressure -peak pressure -respiratory minute volume and -catecholamine dose (max daily day 1-6) -duration of mechanical ventilation (days) -mortality (30 days or until ICU-discharge -SOFA-score (day 1-6) -blood-to-dialysate-ratio

—

Countries

Germany

Contacts

Public ContactPhilipp Enghard

Charité - Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin

philipp.enghard@charite.de+49 (0) 30 450 614 016

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026