Norwegian Intensive Care Unit Dalteparin Effect Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Norwegian Intensive Care Unit Dalteparin Effect Study

Conditions
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Acute Kidney Injury, Deep Venous Thrombosis

Intervention / Treatment
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* Device: Continuous venovenous hemodialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients with AKI<br>ICU patients with AKI treated with continuous venovenous hemodialysis | Device: Continuous venovenous hemodialysis<br>* Continuous venovenous hemodialysis<br>* Other names: CRRT;|
| ICU patients without AKI<br>ICU patients without AKI defined as RIFLE group O and R | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Twice a week until ICU LOS 30 days or discharge from ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Blood samples is drawn 4 times during ICU stay, from minimum day 2 to maximum day 30 dependent on the dialysis therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Deep venous thrombosis, Dialysis, Prophylaxis