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Completed

NCT Number: NCT02595619

Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RRT plus ECCO2R

Device

Patients with acute kidney injury will be treated with Renal replacement therapy associated to extracorporeal carbon dioxide removal in a single treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Combined Strategy of Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal in Patients With Acute Kidney Injury

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2015
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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