Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595619
• Other study ID #: CE 0068144
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: December 22, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2017
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values		72 hours
Secondary	Evaluation of inflammatory mediators release in plasma samples of patients	Plasma Concentrations of interleukin 6, interleukin 8, interleukin 1 beta, tumor necrosis factor alpha	72 hours
Secondary	Assessment of the changes in pH		72 hours
Secondary	Assessment of the changes in PaCO2		72 hours
Secondary	Assessment of the changes in PaO2		72 hours