"Low Flow" CO2 Removal on RRT

Renal Replacement Therapy Clinical Trial

— Prismalung  

Official title:

"Low Flow" CO2 Removal Via a Membrane Gas Exchange Device (Prismalung®) on a Renal Replacement Platform (Prismaflex®) in Hypercapnic, Ventilated Patients Requiring Renal Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590575
• Other study ID #: SZ_G_023.14-II-4
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: May 11, 2017
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of a membrane gas exchange device in the venovenous circulation of a continuous renal replacement therapy for the purpose of CO2 elimination and pH compensation. Thus, the primary endpoint is the modification of the PaCO2 and/or the ventilator settings (tidal volume VT and plateau pressure Pplat).

Description:

Protocol synopsis Study title "Low flow" CO2 removal via a membrane gas exchange device (Prismalung®) on a renal replacement platform (Prismaflex®) in hypercapnic, ventilated patients requiring renal replacement therapy Brief description Prismalung Study Indication Hypercapnic, ventilated, and renal replacement therapy requiring patients Primary study goal Changes in the arterial pCO2 value Secondary study goals Changes in the acid-base balance Changes of tidal volumes/ventilation pressures Changes in hemodynamics Study design Prospective intervention study (pilot study)

Study population Inclusion criteria:

1. Necessity of renal replacement therapy

2. Necessity of ventilation therapy with an expected duration >24 hrs. in mild to moderate ARDS according to the "Berlin Definition" (300≥PaO2/FiO2>100mmHg, ventilated acc. to the ARDS network strategy with VT 6 ml/kgKG (KG = Körpergewicht, body weight) and PEEP ≥ 5 cmH2O)Pneumonia, pulmonary vasculitis, COPD, or other pulmonary disorder

3. PaCO2 ≥ 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30

4. Written consent by patient or legal representative

Number of patients n = 20 Interventions 1. With ongoing continuous hemofiltration and mechanical ventilation additional membrane gas exchange device (Prismalung®) in the renal replacement circulation; measurements of the effects on PaCO2 under varying blood and sweep gas flows 2. Afterwards, reduction of the tidal volume (VT) / plateau pressure until reaching the initial PaCO2value Study drug None Primary endpoint 1. Changes in the PaCO2 / acid-base status (BGA) 2. Changes of the VT / plateau pressure in the ventilation (ventilation settings) Secondary endpoints Changes in the systemic hemodynamics Vasopressor dosage BGA, renal values, lactate PaCO2 before and after gas exchange device Lifetimes of the extracorporeal circulation Complications Study site Intensive care units Medizinische Klinik 4, Uniklinikum Erlangen-Nürnberg Medizinische Klinik 4, Klinikum Nürnberg Süd Klinik für Intensivmedizin Universitätsklinikum Hamburg Eppendorf Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Frankfurt a. M. Timeline Start in October 2015 Anticipated study duration: 6 months Financing Baxter Gambro Renal GmbH (Ltd)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Necessity of renal replacement therapy

2. Necessity of ventilation therapy with an expected duration >24 hrs. in mild to moderate ARDS according to the "Berlin Definition" (300=PaO2/FiO2>100mmHg, ventilated acc. to the ARDS network strategy with VT 6 ml/kgKG (KG = Körpergewicht, body weight) and PEEP = 5 cmH2O) Pneumonia, pulmonary vasculitis, COPD, or other pulmonary disorder

3. PaCO2 = 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30

4. Written consent by patient or legal representative

Exclusion Criteria:

1. Age < 18 years

2. Pregnancy

3. BMI > 40 kg/m2

4. Decompensated heart failure or acute stroke

5. Severe ARDS (PaO2/FiO2 < 100 mmHg)

6. Acute cranio-cerebral injury

7. Severe liver failure (Child-Pugh score >7)

8. Heparin-induced thrombopenia (HIT II)

9. Contraindications to the performance of CVVH (continuous venovenous hemofiltration)

10. Contraindications to systemic anticoagulation

11. Lacking possibility of access via a dialysis catheter

12. Surgeries scheduled within 48 hrs of inclusion in the study

13. Advanced tumor disorder with life expectancy < 1 month

14. Moribund patients, decision to forego therapy

15. Lacking consent

16. Participation in a different intervention study

Related Conditions & MeSH terms

• Renal Replacement Therapy

Intervention

Device:
• Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform
With ongoing continuous hemofiltration and mechanical ventilation additional membrane gas exchange device (Prismalung®) in the renal replacement circulation; measurements of the effects on PaCO2 under varying blood and sweep gas flows Afterwards, reduction of the tidal volume (VT) / plateau pressure until reaching the initial PaCO2value

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuernberg	Nuernberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Universitätsklinikum Hamburg-Eppendorf, University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the PaCO2, acid-base status (BGA)		hours to 3 days
Primary	Changes of the VT / plateau pressure in the ventilation (ventilation settings)		hours to 3 days
Secondary	Changes in mean arterial pressure (mmHg)		hours to 3 days
Secondary	Changes in heart rate (bpm)		hours to 3 days
Secondary	Changes in norepinephrin dose (mg/h)		hours to 3 days
Secondary	Changes in Serum lactate concentration (mmol/l)		hours to 3 days
Secondary	Arterial pO2 and pCO2 (mmHg)		hours to 3 days
Secondary	Arterial bicarbonate concentration (mmol/l)		hours to 3 days
Secondary	Standard Base Excess (mmol/l)		hours to 3 days
Secondary	Changes in Serum creatinine (mg/dl)		hours to 3 days
Secondary	PCO2 before and after gas exchange device (mmHg)		hours to 3 days
Secondary	Lifetime of extracorporeal circuit in hours (Duration from start to end of RRT)		hours to 3 days
Secondary	Number and kind of adverse events during study period deemed clinically significant by investigator (as documented by paper questionnaire)		hours to 3 days