Norwegian Intensive Care Unit Dalteparin Effect Study

NCT ID: NCT01721928

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-03
• Study Completion Date: 2017-03-01

Brief 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. 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.

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).

Conditions

Acute Kidney Injury; Deep Venous Thrombosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU patients with AKI

ICU patients with AKI treated with continuous venovenous hemodialysis

Continuous venovenous hemodialysis

Intervention Type: DEVICE

Continuous venovenous hemodialysis

ICU patients without AKI

ICU patients without AKI defined as RIFLE group O and R

No interventions assigned to this group

Interventions

Continuous venovenous hemodialysis

Continuous venovenous hemodialysis

Intervention Type: DEVICE

Other Intervention Names

CVVHD; CRRT

Eligibility Criteria

Inclusion Criteria

• ICU patients receiving prophylactic dalteparin

Exclusion Criteria

• Age < 18 years
• Intraocular bleeding
• Intracranial bleeding
• Acute spinal cord lesion
• Inherited coagulopathy
• Ongoing, uncontrolled bleeding
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sigrid Beitland

Oslo University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjetil Sunde, Professor

Role: STUDY_CHAIR

Oslo University Hospital

Sigrid Beitland, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Per M Sandset, Professor

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

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Other Identifiers

UiO

Identifier Type: OTHER

Identifier Source: secondary_id

2012/942

Identifier Type: -

Identifier Source: org_study_id