Oslo University Hospital
Oslo, 0540, Norway
NCT Number: NCT01721928
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.
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Notify Me18 year and older
All sexes
Observational
Oslo, 0540, Norway
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous venovenous hemodialysis
Other names: CVVHD, CRRT
Time frame: Twice a week until ICU LOS 30 days or discharge from ICU
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.
Time frame: Blood samples is drawn 4 times during ICU stay, from minimum day 2 to maximum day 30 dependent on the dialysis therapy
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.
Time frame: Whole blood will be drawn on two separate days from minimum day 2 to maximum day 30 dependent on the dialysis therapy, immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin.
The blood sample analyses anti-Xa activity, TEG and TGA will be analysed, and their ability to detect critically ill patients who will subsequently develop DVT. Different patients with and without AKI will be compared. Samples from the same patients one day with and one day without dialysis therapy will also be compared.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
The following factors will be assessed: Presence of AKI, dialysis therapy, Body mass index (BMI), gender, high severity of illness, use of vasopressors, presence of oedema and serum antithrombin concentrations.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Compare the incidence of DVT and bleeding among ICU patients with and without CiCa-dialysis. Investigate if patient with bleeding have different anti-Xa activity levels, TGA and TEG than patients without bleeding, and if patients with DVT have different anti-Xa activity levels, TGA and TEG compared to patients without DVT.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared in selected ICU patients with and without CRRT.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared with global perfusion measured as cardiac index using a pulse contour analysis device (PICCO®).
Time frame: During ICU stay until LOS 30 days or discharge from ICU
NMR spectroscopy of urine in ICU patients with and without AKI necessitating CRRT will be compared, and levels in the same patients with and without dialysis therapy. Further, NMR spectroscopy of urine in the same patient with and without dialysis therapy will be compared.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Collect data on filter clotting. Evaluate the predictive value of different bedside methods clinically used to forecast filter clotting: Post filter ionised calcium, heparin-active R-time during TEG, access pressure, filter pressure, return pressure and visual inspection of the dialysis circuit air trap.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Collect data on filter lifetime during CiCa-dialysis therapy and investigate if there is a correlation between measured filter lifetime and the following factors: Heparin effect, antithrombin levels, post filter ionised calcium, NMR spectroscopy of urine, clinical assessment of clotting as well as anatomical placement of the dialysis catheter.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Prospective collection of data on risk factor for DVT in an ICU population according to international guidelines. Also screening for DVT in an ICU population using DUS. Thereafter we plan to perform an analysis on the contribution of each risk factor and combinations of risk factors on development of DVT, with special attention towards possible avoidable risk factors.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
Compare the incidence of catheter related DVT if CVC and dialysis catheters are placed in the femoral, subclavian and internal jugular veins.
Time frame: Data will be collected during ICU stay until LOS 30 days or discharge from ICU. Mortality will also be assessed after ICU discharge.
To compare preset prognostic markers for morbidity (ICU and hospital length of stay in addition to time on ventilator and dialysis therapy) and mortality (ICU mortality and 30 days mortality) in patients with and without presence of DVT.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
To compare arterial blood gases in ICU patients with and without CiCa-dialysis and evaluate if patients treated with dialysis more often have metabolic alkalosis. Further, to study whether there is an association between presence of metabolic alkalosis and time spent on ventilator therapy.
Time frame: During ICU stay until LOS 30 days or discharge from ICU
To compare occurrence of DVT and its correlation to compliance to clinical practice guidelines for DVT prophylaxis, including pharmacological and non-pharmacological prophylaxis.
Time frame: Patients will be screened for DVT 3 months after ICU discharge.
To find the occurrence of DVT in critically ill patients 3 months after ICU discharge. Survivors who did not develop DVT during ICU stay will be screened for DVT after 3 months using DUS examination.
Time frame: Blood and urine samples will be collected during ICU stay until LOS 30 days or discharge from ICU. The samples will be stored for future analysis with a maximum of 10 years storage.
To compare blood and urine samples from critically ill patients with and without AKI and dialysis therapy. The blood and urin samples can be stored for maximum 10 years. The plan is to use new, yet not known analysis methods, and test their utility when assessing ICU patients with and without AKI and dialysis therapy.
Oslo University Hospital
Other
Acronym: NORIDES
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