Renal Replacement TherapyPrismalungNCT02590575
"Low Flow" CO2 Removal on RRT
A study testing Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform in people with Renal Replacement Therapy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy
- What is being tested?
- Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Pregnancy
- BMI > 40 kg/m2
- Decompensated heart failure or acute stroke
- Severe ARDS (PaO2/FiO2 < 100 mmHg)
- Acute cranio-cerebral injury
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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)
- Conditions
- Renal Replacement Therapy
- Being tested
- Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform
- Keywords
- extracorporeal CO2 removal, renal replacement therapy, Prismalung, ARDS, hypercapnia, Changes in the arterial pCO2 value, ventilated, Hypercapnic
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platformDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| CO2 removal | Other | Not described Receives: Device: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the PaCO2, acid-base status (BGA)
Measured: hours to 3 days
Changes of the VT / plateau pressure in the ventilation (ventilation settings)
Measured: hours to 3 days
Secondary outcomes (11)
Changes in mean arterial pressure (mmHg)
Measured: hours to 3 days
Changes in heart rate (bpm)
Measured: hours to 3 days
Changes in norepinephrin dose (mg/h)
Measured: hours to 3 days
Changes in Serum lactate concentration (mmol/l)
Measured: hours to 3 days
Arterial pO2 and pCO2 (mmHg)
Measured: hours to 3 days
Arterial bicarbonate concentration (mmol/l)
Measured: hours to 3 days
Standard Base Excess (mmol/l)
Measured: hours to 3 days
Changes in Serum creatinine (mg/dl)
Measured: hours to 3 days
PCO2 before and after gas exchange device (mmHg)
Measured: hours to 3 days
Lifetime of extracorporeal circuit in hours (Duration from start to end of RRT)
Measured: hours to 3 days
Number and kind of adverse events during study period deemed clinically significant by investigator (as documented by paper questionnaire)
Measured: hours to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Goethe University
- Responsible party
- Principal investigator, stefan john, University of Erlangen-Nürnberg Medical School
- Investigators
- Stefan John, MD, Principal investigator, University of Erlangen-Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590575
- Sponsor's protocol ID
- SZ_G_023.14-II-4
- Acronym
- Prismalung
- Status last verified
- May 2017
- First submitted
- 23 Oct 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30617611
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02590575
- Acronym / sponsor ID
- Prismalung / SZ_G_023.14-II-4
- Conditions
- Renal Replacement Therapy
- Keywords
- extracorporeal CO2 removal, renal replacement therapy, Prismalung, ARDS, hypercapnia, Changes in the arterial pCO2 value, ventilated, Hypercapnic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Goethe University
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO2 removal | Other | Device: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Age < 18 years
- Pregnancy
- BMI > 40 kg/m2
- Decompensated heart failure or acute stroke
- Severe ARDS (PaO2/FiO2 < 100 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform1. 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 | Device | CO2 removal |
Primary outcome
Changes in the PaCO2, acid-base status (BGA)
Time frame: hours to 3 days
Changes of the VT / plateau pressure in the ventilation (ventilation settings)
Time frame: hours to 3 days
11 secondary outcomes
Changes in mean arterial pressure (mmHg)
Time frame: hours to 3 days
Changes in heart rate (bpm)
Time frame: hours to 3 days
Changes in norepinephrin dose (mg/h)
Time frame: hours to 3 days
Changes in Serum lactate concentration (mmol/l)
Time frame: hours to 3 days
Arterial pO2 and pCO2 (mmHg)
Time frame: hours to 3 days
Arterial bicarbonate concentration (mmol/l)
Time frame: hours to 3 days
Standard Base Excess (mmol/l)
Time frame: hours to 3 days
Changes in Serum creatinine (mg/dl)
Time frame: hours to 3 days
PCO2 before and after gas exchange device (mmHg)
Time frame: hours to 3 days
Lifetime of extracorporeal circuit in hours (Duration from start to end of RRT)
Time frame: hours to 3 days
Number and kind of adverse events during study period deemed clinically significant by investigator (as documented by paper questionnaire)
Time frame: hours to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 30617611Nentwich 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.
Related trials for Renal Replacement Therapy
Recruiting
Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Acute Kidney Failure Stage 3, Continuous Renal Replacement Therapy (CRRT)
RecruitingPhase 3
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Recruiting
Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
AKI - Acute Kidney Injury, Fluid Balance
Not yet recruitingObservational study
Machine Learning and Artificial Intelligence Algorithms to Optimize the Performance and Delivery of Acute Dialysis
Renal Dialysis, Renal Replacement Therapy
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan John, MD principal investigator
University of Erlangen-Nuernberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform in people with Renal Replacement Therapy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the PaCO2, acid-base status (BGA) (time frame: hours to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.