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Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

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ClinicalTrials.gov Identifier: NCT02595619
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Vito Fanelli MD, PhD, University of Turin, Italy

Brief Summary:
This study aims to assess whether in patients with acute kidney injury (AKI) requiring mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Device: RRT plus ECCO2R Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Strategy of Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal in Patients With Acute Kidney Injury
Actual Study Start Date : December 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RRT plus ECCO2R Device: RRT plus ECCO2R
Patients with acute kidney injury will be treated with Renal replacement therapy associated to extracorporeal carbon dioxide removal in a single treatment




Primary Outcome Measures :
  1. Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Evaluation of inflammatory mediators release in plasma samples of patients [ Time Frame: 72 hours ]
    Plasma Concentrations of interleukin 6, interleukin 8, interleukin 1 beta, tumor necrosis factor alpha

  2. Assessment of the changes in pH [ Time Frame: 72 hours ]
  3. Assessment of the changes in PaCO2 [ Time Frame: 72 hours ]
  4. Assessment of the changes in PaO2 [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute kidney injury (AKI) requiring renal-replacement therapy and mechanical ventilation of duration ≥ 48 hours

Exclusion Criteria:

  • little chance of survival at 24 h (according to clinical judgment), pregnancy, mechanical ventilation with expected duration lower than 48h, age under 18 and over 90

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595619


Locations
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Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy

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Responsible Party: Vito Fanelli MD, PhD, Assistant Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02595619     History of Changes
Other Study ID Numbers: CE 0068144
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Keywords provided by Vito Fanelli MD, PhD, University of Turin, Italy:
AKI
Extracorporeal Carbon Dioxide Removal
Renal Replacement Therapy
Mechanical Ventilation
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases