NCT05842369

Brief Summary

The aim of the study is to investigate the effects of ADVOS® therapy in critically ill patients with acute kidney injury, necessity of renal replacement therapy and acidosis. The investigators aim at assessing superiority of ADVOS® versus CVVHD for the primary outcome hours alive with normal pH (arterial pH ≤ 7,35) until 24 hours in a modified intention-to-treat analysis (mITT: replacement if dropped out before treatment start).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

April 2, 2023

Last Update Submit

May 6, 2023

Conditions

Metabolic Acidosis

Keywords

acidosisdialysisacute kidney injuryrenal replacement therapyintensive care medicineADVOS

Outcome Measures

Primary Outcomes (1)

  • Hours alive with normal pH (≥ 7.35) within first 24 hours of therapy

    pH values are measured to determine acidaemia in critically ill patients. As defined by the study protocol, pH ≤ 7.25 and base excess ≤ -6 mmol/l are required to diagnose metabolic or mixed acidosis. Normalisation of pH (defined as ≥ 7.35, representing the lower margin of the pyhsiological pH range) is used as a surrogate marker for reversal of acedaemia and, thereby, device effectiveness. The time (hours) alive within the defined physiological range after initiation of therapy in the first 24 hours will be used to compare the intervention and control group.

    First 24 hours after initiation of study-specific therapy

Secondary Outcomes (11)

  • Time to first pH normalisation (≥ 7.35)

    First 24 hours after initiation of study-specific therapy

  • Days free of mechanical ventilation within the first 28d after randomization

    From start of study-specific therapy until day 28

  • Days free of vasopressor therapy within the first 28d after randomization

    From initiation of study-specific therapy until day 28

  • Days free of renal replacement therapy within the first 28d after randomization

    Assessment at baseline, days 1, 2, 3, 7, 14, 21, 28 as long as patient is still on intensive care unit

  • Course of severity of organ failure

    Assessment at baseline, days 1, 2, 3, 7, 14, 21, 28 as long as patient is still on intensive care unit

  • +6 more secondary outcomes

Study Arms (2)

ADVOS

EXPERIMENTAL

Application of the ADVOS device for

Device: ADVOS

CVVHD

ACTIVE COMPARATOR

Application of CVVHD

Device: CVVHD

Interventions

ADVOSDEVICE

Modulation of acid-base regulation in patients with acute kidney injury, meta- bolic or mixed acidosis and indication for renal replacement therapy

Also known as: ADVOS® device; ADVITOS
ADVOS
CVVHDDEVICE

Modulation of acid-base regulation in patients with acute kidney injury, meta- bolic or mixed acidosis and indication for renal replacement therapy

Also known as: multiFiltrate / multiFiltratePRO
CVVHD

Eligibility Criteria

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

You may qualify if:

  • Metabolic or mixed acidosis with pH ≤ 7.25 and base excess ≤ -6 mmol/l
  • Age ≥ 18 years
  • Acute kidney injury with need for Renal Replacement Therapy (RRT)

You may not qualify if:

  • Pregnancy
  • Wards of the state/Prisoners
  • Expected survival of less than 24 hours
  • Contraindication for citrate anticoagulation
  • Extracorporeal membrane oxygenation (ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

AcidosisAcute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Olaf Boenisch

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olaf Boenisch, MD

CONTACT

+4940741035315o.boenisch@uke.de

Dominik Jarczak, MD

CONTACT

+4940741035315d.jarczak@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2023

First Posted

May 6, 2023

Study Start

April 17, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)