The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD)

NCT02107222 | Withdrawn DMC

• 1 other identifier: MAQ/COPD/PALP/2012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients with COPD Exacerbation and Respiratory Failure

Conditions

COPD; Chronic Obstructive Pulmonary Disease

Keywords

COPD; Exacerbation; invasive ventilation; CO2-Removal

Outcome Measures

Primary Outcomes (1)

• Difference in time of mechanical ventilation

  • To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation.

  720 hours

Study Arms (2)

mechanical ventilation (MV)

NO INTERVENTION

mechanical ventilation according to guidelines

MV + ECCO2-R(PALP-Device/MaquetCP)

EXPERIMENTAL

MV according to the guidelines plus CO2-Removal with PALP

Device: CO2-Removal (PALP-Device/MaquetCP)

Interventions

CO2-Removal (PALP-Device/MaquetCP) DEVICE

extracorporeal circuit to remove CO2 out of the blood

MV + ECCO2-R(PALP-Device/MaquetCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, and ≥40 years of age
• Known history of COPD
• Currently experiencing an exacerbation of COPD
• P/F ratio \>150 mmHg
• Currently endotracheally intubated and requiring invasive mechanical ventilation (must have been on invasive mechanical ventilation for 24-48 hours)
• Able to tolerate large bore intravenous (IV) cannulation required for proper operation of study device
• For female patients of child-bearing potential, a negative urine or serum pregnancy test at screening; all female patients will be considered of child-bearing potential unless they are post menopausal for at least 1 year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
• Written informed consent obtained according to local regulations; or, if unable to provide written informed consent due to incapacitation, a legally authorized representative is able to provide written informed consent on behalf of the patient

You may not qualify if:

• Any end-stage medical conditions with expected survival \<6 months
• Tracheostomy
• Unable to provide central venous access
• Acute brain injury
• Any legally authorized document(s) that may restrict aggressive medical management such as "Do Not Resuscitate," "Do Not Intubate," etc.
• Risk of bleeding or clotting such as:
• Known bleeding diathesis or abnormal clotting
• Recent or current use of medications known to increase risk of bleeding
• Screening platelet count of \<75,000/mm3 or international normalized ratio (INR) \>1.5 or activated partial thromboplastin time (aPTT) \>1.5 times the upper limit of normal (ULN) range for their respective laboratory values
• Any recognized contra indications to systemic anticoagulation therapy or use of heparin
• Body mass index (BMI) \>35
• Any form of chronic hyperventilation not related to COPD
• Hemodynamic instability or requiring significant vasopressor support
• Cardiogenic or noncardiogenic pulmonary edema as the primary reason for respiratory failure
• High risk cardiac conditions

Sponsors & Collaborators

• Maquet Cardiopulmonary GmbH: lead

Study Sites (1)

MAQUET Cardiopulmonary AG

Rastatt, 76437, Germany

Location

Related Publications (1)

• Abrams DC, Brenner K, Burkart KM, Agerstrand CL, Thomashow BM, Bacchetta M, Brodie D. Pilot study of extracorporeal carbon dioxide removal to facilitate extubation and ambulation in exacerbations of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013 Aug;10(4):307-14. doi: 10.1513/AnnalsATS.201301-021OC.

  PMID: 23952848 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco V Ranieri, MD PhD

  Investigational institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 8, 2014
• Primary Completion: December 1, 2016
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

DE (1)