Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Device: RRT plus ECCO2R

• Registration Number: NCT02595619
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Study Start: 2015-12
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RRT plus ECCO2R	RRT plus ECCO2R	-

Primary Outcome Measures

Name	Time	Method
Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values	72 hours

Secondary Outcome Measures

Name	Time	Method
Assessment of the changes in PaCO2	72 hours
Assessment of the changes in pH	72 hours
Assessment of the changes in PaO2	72 hours
Evaluation of inflammatory mediators release in plasma samples of patients	72 hours	Plasma Concentrations of interleukin 6, interleukin 8, interleukin 1 beta, tumor necrosis factor alpha

Trial Locations

Locations (1)

Azienda Ospedaliera Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy