NCT02590575

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

October 23, 2015

Last Update Submit

May 11, 2017

Conditions

Renal Replacement Therapy

Keywords

extracorporeal CO2 removalrenal replacement therapyPrismalungARDShypercapniaChanges in the arterial pCO2 valueventilatedHypercapnic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

CO2 removal

OTHER
Device: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform

Interventions

Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platformDEVICE

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

CO2 removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Advanced tumor disorder with life expectancy \< 1 month
  • Moribund patients, decision to forego therapy
  • Lacking consent
  • Participation in a different intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Erlangen-Nuernberg

Nuremberg, 90473, Germany

Location

Related Publications (1)

  • Nentwich J, Wichmann D, Kluge S, Lindau S, Mutlak H, John S. Low-flow CO2 removal in combination with renal replacement therapy effectively reduces ventilation requirements in hypercapnic patients: a pilot study. Ann Intensive Care. 2019 Jan 7;9(1):3. doi: 10.1186/s13613-019-0480-4.

    PMID: 30617611DERIVED

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan John, MD

    University of Erlangen-Nuernberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Stefan John

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

DE(1)