Acute Kidney InjuryCIPOHANCT03969966
Citrate Anticoagulation for Postdilution Hemofiltration
An observational study of Acute Kidney Injury and Critical Illness, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Critical Illness
- What is being tested?
- renal replacement therapy as clinically indicated
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Critically ill patients at ICU with acute kidney injury
Who may be able to join
- acute kidney injury
- critical illness and treatment at ICU
Who cannot join
- age < 18 years
- pregnancy or breast feeding
- severe lactate acidosis ( > 10 mmol/l) for longer than 6 hours and pH < 7.2
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Kindgen-Milles, MD, +49 211 81 ext. 07049, kindgen-milles@med.uni-duesseldorf.de
Detlef Kindgen-Milles, Prof.
About this study
This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.
Read the detailed description
Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects.
We here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol.
We will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.
- Conditions
- Acute Kidney Injury, Critical Illness
- Being tested
- renal replacement therapy as clinically indicated
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapy as clinically indicatedOther
Continuous renal replacement therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter running time
Filterlifetime with regional citrate anticoagulation for haemofiltration
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start14 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Diamed GmbH, Cologne, Germany
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969966
- Sponsor's protocol ID
- 2018-82
- Acronym
- CIPOHA
- Status last verified
- May 2020
- First submitted
- 29 May 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dimski T, Brandenburger T, Vollmer C, Kindgen-Milles D. A safe and effective protocol for postdilution hemofiltration with regional citrate anticoagulation. BMC Nephrol. 2024 Jul 9;25(1):218. doi: 10.1186/s12882-024-03659-y.
PubMed 38982339
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrate Anticoagulation for Postdilution Hemofiltration
- ClinicalTrials.gov ID
- NCT03969966
- Acronym / sponsor ID
- CIPOHA / 2018-82
- Conditions
- Acute Kidney Injury, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Diamed GmbH, Cologne, Germany
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.
Detailed description
Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects.
We here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol.
We will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients at ICU with acute kidney injury
Key inclusion criteria (2 listed)
- acute kidney injury
- critical illness and treatment at ICU
Key exclusion criteria (3 listed)
- age < 18 years
- pregnancy or breast feeding
- severe lactate acidosis ( > 10 mmol/l) for longer than 6 hours and pH < 7.2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal replacement therapy as clinically indicatedContinuous renal replacement therapy | Other | – |
Primary outcome
Filter running time
Time frame: 72 hours
Filterlifetime with regional citrate anticoagulation for haemofiltration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 38982339Dimski T, Brandenburger T, Vollmer C, Kindgen-Milles D. A safe and effective protocol for postdilution hemofiltration with regional citrate anticoagulation. BMC Nephrol. 2024 Jul 9;25(1):218. doi: 10.1186/s12882-024-03659-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Düsseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Critical Illness, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter running time (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.