Increasing Target Plasma Bicarbonate (HCO3) Concentrations for Lung-Protective Ventilation in Individuals with Acute Respiratory Distress Syndrome (ARDS) requiring Continuous Kidney Replacement Therapy (CKRT) (The BigBic Study II)

Increasing Target Plasma Bicarbonate (HCO3) Concentrations for Lung-Protective Ventilation in Individuals with Acute Respiratory Distress Syndrome (ARDS) requiring Continuous Kidney Replacement Therapy (CKRT) (The BigBic Study II) - BigBic 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035418

Enrollment

100

Registered

2024-11-04

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

J80 N17 R06.8 E87.2

Interventions

Group 1: Modified citrate-based continuous kidney replacement therapy aiming for a plasma HCO3 concentration of 30mmol/l by adaption of the blood to dialysate ratio. Group 2: Standard citrate-based co

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Acute respiratory distress syndrome (ARDS) - Invasive ventilation - Citrate-based continuous kidney replacement therapy

Exclusion criteria

Exclusion criteria: - Extracorporeal membrane oxygenation - Severe liver failure (bilirubin > 8mg/dl and INR>2) - Severe lactic acidosis (lactate > 80mg/dl)

Design outcomes

Primary

Measure	Time frame
Mean tidal volume difference on days 2 and 3	—

Secondary

Measure	Time frame
Inspiratory pressure, driving pressure, mechanical power of ventilation, ventilator-free days by day 28, proportion of patients receiving lung-protective ventilation (6mL tidal volume / kg predicted bodyweight), proportion of primary extubation vs. tracheotomy, extrapulmonary organ dysfunction, proportion of patients initiated on extracorporeal membrane oxygenation, mortality (until ICU discharge or a maximum of 28 days after inclusion), outcomes among patients receiving ultra-lung-protective, lung-protective, and non-lung-protective ventilation.	—

Measure

Time frame

Inspiratory pressure, driving pressure, mechanical power of ventilation, ventilator-free days by day 28, proportion of patients receiving lung-protective ventilation (6mL tidal volume / kg predicted bodyweight), proportion of primary extubation vs. tracheotomy, extrapulmonary organ dysfunction, proportion of patients initiated on extracorporeal membrane oxygenation, mortality (until ICU discharge or a maximum of 28 days after inclusion), outcomes among patients receiving ultra-lung-protective, lung-protective, and non-lung-protective ventilation.

—

Countries

Germany

Contacts

Public ContactJulius Kunz

Department of Nephrology and Medical Intensive Care Charité - Universitätsmedizin Berlin

julius-valentin.kunz@charite.de030 450 614636

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026