Prismalung: "Low Flow" CO2 Removal on RRT

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT02590575

Collaborator

Universitätsklinikum Hamburg-Eppendorf (Other), University Hospital Frankfurt (Other)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Renal Replacement Therapy	Device: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform	N/A

Detailed 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:

Necessity of renal replacement therapy
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
PaCO2 ≥ 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30
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)

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: CO2 removal	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

Arm

Intervention/Treatment

Other: CO2 removal

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

Outcome Measures

Primary Outcome Measures

Changes in the PaCO2, acid-base status (BGA) [hours to 3 days]
Changes of the VT / plateau pressure in the ventilation (ventilation settings) [hours to 3 days]

Secondary Outcome Measures

Changes in mean arterial pressure (mmHg) [hours to 3 days]
Changes in heart rate (bpm) [hours to 3 days]
Changes in norepinephrin dose (mg/h) [hours to 3 days]
Changes in Serum lactate concentration (mmol/l) [hours to 3 days]
Arterial pO2 and pCO2 (mmHg) [hours to 3 days]
Arterial bicarbonate concentration (mmol/l) [hours to 3 days]
Standard Base Excess (mmol/l) [hours to 3 days]
Changes in Serum creatinine (mg/dl) [hours to 3 days]
PCO2 before and after gas exchange device (mmHg) [hours to 3 days]
Lifetime of extracorporeal circuit in hours (Duration from start to end of RRT) [hours to 3 days]
Number and kind of adverse events during study period deemed clinically significant by investigator (as documented by paper questionnaire) [hours to 3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Necessity of renal replacement therapy
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
PaCO2 ≥ 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30
Written consent by patient or legal representative

Exclusion Criteria:

Age < 18 years
Pregnancy
BMI > 40 kg/m2
Decompensated heart failure or acute stroke
Severe ARDS (PaO2/FiO2 < 100 mmHg)
Acute cranio-cerebral injury
Severe liver failure (Child-Pugh score >7)
Heparin-induced thrombopenia (HIT II)
Contraindications to the performance of CVVH (continuous venovenous hemofiltration)
Contraindications to systemic anticoagulation
Lacking possibility of access via a dialysis catheter
Surgeries scheduled within 48 hrs of inclusion in the study
Advanced tumor disorder with life expectancy < 1 month
Moribund patients, decision to forego therapy
Lacking consent
Participation in a different intervention study