AzTrials
AzTrials

Acute Kidney InjuryNORIDESNCT01721928

Norwegian Intensive Care Unit Dalteparin Effect Study

An observational study of Acute Kidney Injury and Deep Venous Thrombosis, run by Oslo University Hospital at 1 site in Norway.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of the NORIDES study is to investigate the effect of pharmacological thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury, Deep Venous Thrombosis
What is being tested?
Continuous venovenous hemodialysis
Type of treatment
Medical device
How many people
70 participants
Where
1 siteNorway
Study dates
3 Dec 2012to 1 Mar 2017
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
  • No healthy volunteers
  • Adult, Older adult

Study population: The main objective is to compare the prophylactic effect of dalteparin in intensive care unit patients with acute kidney injury and continuous renal replacement therapy with a control group of intensive care unit patients with normal kidney function.

Who may be able to join

  • ICU patients receiving prophylactic dalteparin

Who cannot join

  • Age < 18 years
  • Intraocular bleeding
  • Intracranial bleeding
  • Acute spinal cord lesion
  • Inherited coagulopathy
  • Ongoing, uncontrolled bleeding
Show all 14Show fewer
  • Therapeutic anticoagulation
  • Uncorrected coagulopathy
  • Pregnancy or postpartum < 6 weeks
  • Participation in an interventional study
  • RIFLE class E
  • Consent not received
  • ICU length of stay less than 48 hours
  • DVT detected at first DUS examination

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0540

Other trials in Norway

About this study

The main purpose of the NORIDES study is to investigate the effect of pharmacological thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis. The main objective is to compare the prophylactic effect of dalteparin in intensive care unit (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.

Read the detailed description

Description of deep venous thrombosis (DVT) diagnosis: Screening for DVT using Doppler Ultrasound (DUS) of both upper- and lower extremities will be performed within 48 hours after ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30 days. An additional DUS will be performed 3 months after ICU discharge.

Description of heparin effect measured in blood samples: Blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-Xa activity, thrombin generation assay (TGA) and thrombelastography (TEG) and other haematological analyses including antithrombin concentrations. Whole blood will be drawn on two separate days (from minimum day 2 to maximum day 30 dependent on the dialysis therapy) of ICU stay immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of AKI from the effect of continuous renal replacement therapy (CRRT).

Being tested
Continuous venovenous hemodialysis
Keywords
Acute kidney injury, Deep venous thrombosis, Dialysis, Prophylaxis
Medical subject headings
Acute Kidney Injury, Venous Thrombosis

What participants receive

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

  • Continuous venovenous hemodialysisDevice

    Also called CVVHD, CRRT

    Continuous venovenous hemodialysis

Study groups in NCT01721928
Study groupRoleWhat they receive
ICU patients with AKIICU patients with AKI treated with continuous venovenous hemodialysis
Receives: Device: Continuous venovenous hemodialysis
ICU patients without AKIICU patients without AKI defined as RIFLE group O and R

What is being measured

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

  1. The primary endpoint is development of deep venous thrombosis (DVT)

    Screening for DVT using DUS of both upper- and lower extremities will be performed within 48 hours after ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30 days. An additional DUS will be performed 3 months after ICU discharge.

    Measured: Twice a week until ICU LOS 30 days or discharge from ICU

Secondary outcomes (1)

  1. The secondary endpoint is inadequate heparin effect measured in blood samples

    Blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-Xa activity, TGA and TEG) and other haematological analyses including antithrombin concentrations. Whole blood will be drawn on two separate days immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of AKI from the effect of CRRT.

    Measured: Blood samples is drawn 4 times during ICU stay, from minimum day 2 to maximum day 30 dependent on the dialysis therapy

Timeline

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

  1. First posted6 Nov 2012 (estimated)
  2. Study start3 Dec 2012
  3. Primary completion2 Jun 2016
  4. Study completion1 Mar 2017

Resources

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
Case-control
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01721928
Sponsor's protocol ID
2012/942
Other IDs
UiO
Acronym
NORIDES
Status last verified
Dec 2017
First submitted
26 Oct 2012
Last updated
12 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • McCunn M, Reynolds HN, Reuter J, McQuillan K, McCourt T, Stein D. Continuous renal replacement therapy in patients following traumatic injury. Int J Artif Organs. 2006 Feb;29(2):166-86. doi: 10.1177/039139880602900204.

    PubMed 16552665

  • Cook DJ, Douketis J, Arnold D, Crowther MA. Bleeding and venous thromboembolism in the critically ill with emphasis on patients with renal insufficiency. Curr Opin Pulm Med. 2009 Sep;15(5):455-62. doi: 10.1097/MCP.0b013e32832ea4dd.

    PubMed 19617833

  • Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

    PubMed 15383478

  • Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.

    PubMed 18574271

  • Geerts WH, Heit JA, Clagett GP, Pineo GF, Colwell CW, Anderson FA Jr, Wheeler HB. Prevention of venous thromboembolism. Chest. 2001 Jan;119(1 Suppl):132S-175S. doi: 10.1378/chest.119.1_suppl.132s. No abstract available.

    PubMed 11157647

  • Leclerc JR, Gent M, Hirsh J, Geerts WH, Ginsberg JS. The incidence of symptomatic venous thromboembolism after enoxaparin prophylaxis in lower extremity arthroplasty: a cohort study of 1,984 patients. Canadian Collaborative Group. Chest. 1998 Aug;114(2 Suppl Evidence):115S-118S. doi: 10.1378/chest.114.2_supplement.115s. No abstract available.

    PubMed 9726704

  • Ribic C, Lim W, Cook D, Crowther M. Low-molecular-weight heparin thromboprophylaxis in medical-surgical critically ill patients: a systematic review. J Crit Care. 2009 Jun;24(2):197-205. doi: 10.1016/j.jcrc.2008.11.002. Epub 2009 Feb 7.

    PubMed 19327323

  • Spyropoulos AC, Anderson FA Jr, FitzGerald G, Decousus H, Pini M, Chong BH, Zotz RB, Bergmann JF, Tapson V, Froehlich JB, Monreal M, Merli GJ, Pavanello R, Turpie AGG, Nakamura M, Piovella F, Kakkar AK, Spencer FA; IMPROVE Investigators. Predictive and associative models to identify hospitalized medical patients at risk for VTE. Chest. 2011 Sep;140(3):706-714. doi: 10.1378/chest.10-1944. Epub 2011 Mar 24.

    PubMed 21436241

  • Khouli H, Shapiro J, Pham VP, Arfaei A, Esan O, Jean R, Homel P. Efficacy of deep venous thrombosis prophylaxis in the medical intensive care unit. J Intensive Care Med. 2006 Nov-Dec;21(6):352-8. doi: 10.1177/0885066606292880.

    PubMed 17095499

  • Rabbat CG, Cook DJ, Crowther MA, McDonald E, Clarke F, Meade MO, Lee KA, Cook RJ. Dalteparin thromboprophylaxis for critically ill medical-surgical patients with renal insufficiency. J Crit Care. 2005 Dec;20(4):357-63. doi: 10.1016/j.jcrc.2005.09.009.

    PubMed 16310608

  • Crowther MA, Cook DJ, Griffith LE, Devereaux PJ, Rabbat CC, Clarke FJ, Hoad N, McDonald E, Meade MO, Guyatt GH, Geerts WH, Wells PS. Deep venous thrombosis: clinically silent in the intensive care unit. J Crit Care. 2005 Dec;20(4):334-40. doi: 10.1016/j.jcrc.2005.09.011.

    PubMed 16310604

  • Douketis JD, Rabbat C, Crowther MA; VTE in the ICU Workshop Participants. Anticoagulant prophylaxis in special populations with an indwelling epidural catheter or renal insufficiency. J Crit Care. 2005 Dec;20(4):324-9. doi: 10.1016/j.jcrc.2005.09.001.

    PubMed 16310603

  • Cook D, Crowther MA, Douketis J; VTE in the ICU Workshop Participants. Thromboprophylaxis in medical-surgical intensive care unit patients. J Crit Care. 2005 Dec;20(4):320-3. doi: 10.1016/j.jcrc.2005.09.007. No abstract available.

    PubMed 16310602

  • Cook D, Douketis J, Crowther MA, Anderson DR; VTE in the ICU Workshop Participants. The diagnosis of deep venous thrombosis and pulmonary embolism in medical-surgical intensive care unit patients. J Crit Care. 2005 Dec;20(4):314-9. doi: 10.1016/j.jcrc.2005.09.003. No abstract available.

    PubMed 16310601

  • Cook DJ, Crowther MA, Meade MO, Douketis J; VTE in the ICU Workshop Participants. Prevalence, incidence, and risk factors for venous thromboembolism in medical-surgical intensive care unit patients. J Crit Care. 2005 Dec;20(4):309-13. doi: 10.1016/j.jcrc.2005.09.005. No abstract available.

    PubMed 16310600

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Deep Venous Thrombosis, run by Oslo University Hospital at 1 site in Norway.

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 1 inclusion and 14 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 12 Dec 2017. 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 Norway. 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?

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?

The primary endpoint is development of deep venous thrombosis (DVT) (time frame: Twice a week until ICU LOS 30 days or discharge from ICU). 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 NCT01721928, which also lists 29 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 12 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Norwegian Intensive Care Unit Dalteparin Effect Study | AzTrials