NCT02595619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

October 30, 2015

Last Update Submit

December 22, 2017

Conditions

Acute Kidney Injury

Keywords

AKIExtracorporeal Carbon Dioxide RemovalRenal Replacement TherapyMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values

    72 hours

Secondary Outcomes (4)

  • Evaluation of inflammatory mediators release in plasma samples of patients

    72 hours

  • Assessment of the changes in pH

    72 hours

  • Assessment of the changes in PaCO2

    72 hours

  • Assessment of the changes in PaO2

    72 hours

Study Arms (1)

RRT plus ECCO2R

EXPERIMENTAL
Device: RRT plus ECCO2R

Interventions

RRT plus ECCO2RDEVICE

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

RRT plus ECCO2R

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 3, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

IT(1)