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Acute Kidney InjuryPhase 4RICHNCT02669589

Investigating Different Anticoagulants for Renal Replacement Therapy

A Phase 4 study testing Heparin and Citrate in people with Acute Kidney Injury, run by University Hospital Muenster at 31 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acute Kidney Injury
What is being tested?
Heparin and Citrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
638 participants
Where
31 sitesGermany
Study dates
Mar 2016to 3 Jan 2020
Phase
Phase 4
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)
  • Or
  • Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
  • At least one of the following conditions
  • Sepsis or septic shock
  • Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
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  • Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
  • 18-90 years old
  • Intention to provide full intensive care treatment for at least 3 days
  • Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation

Who cannot join

  • Patients with increased bleeding risk (e.g. an active bleeding from ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, injuries (intracranial hemorrhage, aneurysm of brain arteries) of or surgical procedures on the central nervous system if a heparinization with a target aPTT 45-60 s is not allowed by the treating neurologist or neurosurgeon, severe retinopathies, bleeding into the vitreum, ophthalmic surgical procedures)) or injuries, active tuberculosis; infective endocarditis)
  • Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
  • Dialysis-dependent chronic kidney insufficiency
  • Need of therapeutic systemic anticoagulation
  • Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia
  • AKI caused by permanent occlusion or surgical lesion of the renal artery
Show all 17Show fewer
  • AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction
  • Do-not-resuscitate order
  • Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
  • Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
  • Kidney transplant within the last 12 months
  • Pregnancy and nursing period
  • Abortus imminens
  • No hemofiltration machine free for use at the moment of inclusion
  • Participation in another clinical intervention trial in the last 3 months
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
  • Persons held in an institution by legal or official order

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Germany31 sites

  • University Hospital Aachen

    Aachen, D-52074

  • Klinikum Augsburg

    Augsburg, D-86156

  • HELIOS Klinikum Bad Saarow, Dept. of Intensive Care

    Bad Saarow, D-15526

  • Charité Berlin, Dept. of Anesthesiology and Intensive Care Medicine

    Berlin, 10117

  • Charité Berlin CCM, Medical Department, Division of Nephrology

    Berlin, D-10117

  • Charité Berlin CCV, Medical Department, Division of Nephrology

    Berlin, D-13353

  • Evangelisches Klinikum Bethel gGmbH

    Bielefeld, D-33617

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum, D-44892

  • University Hospital Bonn, Dept.of Anesthesiology and Intensive Care Medicine

    Bonn, D-53127

  • Klinikum Köln-Merheim, Medizinische Klinik I

    Cologne, D-51109

  • University Hospital Duesseldorf, Dept. of Anaesthesiology

    Düsseldorf, D-40225

  • University Hospital Düsseldorf, Dept. of Nephrology

    Düsseldorf, D-40225

  • University Hospital Erlangen

    Erlangen, D-91054

  • University Hospital Essen, Dept. for Nephrology

    Essen, D-45122

  • University Hospital Frankfurt, Dept. of Anesthesiology, Intensive-Care Medicine and Pain Therapy

    Frankfurt, D-60590

  • University Hospital Gießen, Dept. of Anesthesiology and Intensive Care

    Giessen, D-35392

  • University Medical Center Göttingen, Dept. for Anesthesiology

    Göttingen, D-37075

  • University Medicine Greifswald

    Greifswald, D-17475

  • University Hospital Halle, Dept. of Anesthesiology and Intensive Care

    Halle, D-06120

  • University Medical Center Hamburg-Eppendorf, Dept. of Intensive Care

    Hamburg, D-20246

  • University Hospital Heidelberg, Dept. of Anesthesiology

    Heidelberg, D-69120

  • University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine

    Jena, D-07747

  • University Hospital Schleswig-Holstein, Campus Kiel, Dept. for Anaesthesiology and Intensive Care

    Kiel, D-24105

  • Universitätsklinikum Leipzig

    Leipzig, D-04103

  • Universitätsmedizin Mainz

    Mainz, D-55131

  • Technical University of Munich University Hospital, Dept. for Anaesthesiology

    München, D-81675

  • University Hospital Muenster

    Münster, D-48149

  • Klinikum Nürnberg

    Nuremberg, D-90419

  • University Hospital Regensburg, Dept. of Surgery

    Regensburg, D-93042

  • Municipal Hospital Solingen, Dept. for Nephrology and General Internal Medicine

    Solingen, D-42653

  • University Hospital Tuebingen

    Tübingen, D-72076

Other trials in Germany

About this study

Official title: Regional Citrate Versus Systemic Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury

The aim of this study is to evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.

Read the detailed description

Purpose of clinical trial:

To evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.

Patient population: critically ill patients with acute kidney injury requiring renal replacement therapy.

Primary objective:

Anticoagulation of the extracorporeal circuit is required in continuous RRT (CRRT). To this date, it is not clear which anticoagulant should be used for CRRT. Regional citrate anticoagulation (RCA) for CRRT in critically ill patients with AKI prolongs filter life span and reduces 90-day all cause mortality by approximately 8% (from 48% to 40%) compared to systemic heparin anticoagulation for CRRT

Being tested
Heparin, Citrate
Keywords
CRRT, AKI, anticoagulation, KDIGO
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeparinDrug

  • CitrateDrug

Study groups in NCT02669589
Study groupRoleWhat they receive
heparin anticoagulationActive comparatorSystemic anticoagulation of the continuous renal replacement therapy with heparin. Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)
Receives: Drug: Heparin
citrate anticoagulationExperimentalRegional anticoagulation of the continuous renal replacement therapy with citrate. Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l
Receives: Drug: Citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRRT-filter life span in hours

    It will be reported how long the filter will be used during CRRT

    Measured: during continuous renal replacement therapy up to 1 year

  2. Overall survival in a 90day follow-up period

    Measured: 90 days

Secondary outcomes (11)

  1. ICU length of stay in days

    The primary ICU stay will be documented.

    Measured: up to 1 year

  2. Hospital length of stay in days

    Measured: up to 1 year

  3. duration of renal replacement therapy

    within 1 year after randomization

    Measured: 1 year

  4. Bleeding complication

    Measured: intraoperative

  5. Number of patients with administration of red blood cells

    Measured: intraoperative

  6. Rate of infection

    Measured: during primary ICU stay up to 1 year

  7. Major adverse kidney events

    Measured: day 28, 60, 90 and after 1 year after start of CRRT

  8. Complications of therapy

    Measured: intraoperative

  9. Recovery of renal function

    The recovery of renal function will be defined as composite endpoint consisting of lack of dialysis dependency and serum creatinine level no more than 0.5 mg/dl above the baseline value)

    Measured: day 28, 60, 90 and 1 year after start of CRRT

  10. Number of participants with hemodialysis

    Measured: day 28, 60, 90 and 1 year after start of CRRT

  11. Mortality

    Measured: day 28, 60 and 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion3 Apr 2019
  4. Study completion3 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669589
Sponsor's protocol ID
UKM 14_0066
Other IDs
2014-004854-33, 03-AnIt-14, 2014
Acronym
RICH
Status last verified
Feb 2019
First submitted
19 Jan 2016
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • von Groote T, Albert F, Meersch M, Koch R, Gerss J, Arlt B, Sadjadi M, Porschen C, Pickkers P, Zarbock A; RICH investigators. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w.

    PubMed 37430375

  • Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.

    PubMed 33314078

  • Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.

    PubMed 33095849

  • Meersch M, Kullmar M, Wempe C, Kindgen-Milles D, Kluge S, Slowinski T, Marx G, Gerss J, Zarbock A; SepNet Critical Care Trials Group. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial. BMJ Open. 2019 Jan 21;9(1):e024411. doi: 10.1136/bmjopen-2018-024411.

    PubMed 30670518

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Heparin and Citrate in people with Acute Kidney Injury, run by University Hospital Muenster at 31 sites 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRRT-filter life span in hours (time frame: during continuous renal replacement therapy up to 1 year). The study lists 2 primary outcomes in all. 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 NCT02669589, which also lists 4 linked publications.

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 19 Feb 2020.

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