Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

December 22, 2017 updated by: Vito Fanelli MD, PhD, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours
Assessment of the changes in pH
Time Frame: 72 hours
72 hours
Assessment of the changes in PaCO2
Time Frame: 72 hours
72 hours
Assessment of the changes in PaO2
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 0068144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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