Intensive care unit, critically ill patients, VTE prophylaxis Circulatory System Phlebitis and thrombophlebitis of other deep vessels of lower extremities
Conditions
Interventions
Intermittent pneumatic compression combined with pharmacologic prophylaxis compared to pharmacologic prophylaxis.
Patients will be randomized into one of the two intervention arms:
Sponsors
King Abdullah International Medical Research Center
King Abdulaziz City for Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients (male + female) admitted to ICU will be screened for eligibility 1. Medical-Surgical ICU patients >14 years old 2. Weight > 45 kg 3. Expected ICU LOS> 72 hours 4. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 04/04/2017: 1. Patient treated with IPC for > 24 hours in this current ICU admission. 2. Patient in the ICU> 48 hours. 3. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH. 4. Inability or contraindication to applying IPC to both legs or to obtain adequate ultrasound on the lower extremities 4.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings at the site of IPC placement or in the thighs that prevent adequate ultrasounds 4.2. Acute ischemia in the lower extremities 4.3. Amputated foot or leg on one or two sides 4.4. Compartment Syndrome 4.5. Severe peripheral arterial disease 4.6. Vein ligation, gangrene, recent vein grafts, and draining incisions 4.7. Evidence of bone fracture in lower extremities 4.8. Arterial lines in the dorsalis pedis artery 5. Therapeutic dose of anticoagulation with UFH or LMWH 6. Pregnancy 7. Limitation of life support, life expectancy 24 hours in this current ICU admission 2. Patient on pharmacologic prophylaxis with medications other than UFH or LMWH 3. Inability or contraindication to applying IPC to both legs: 3.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement 3.2. Acute ischemia in the lower extremities 3.3. Amputated foot or leg on one or two sides 3.4. Compartment Syndrome 3.5. Severe peripheral arterial disease 3.6. Vein ligation, gangrene, recent vein grafts, and draining incisions 3.7. Evidence of bone fracture in lower extremities 4. The need for therapeutic anticoagulation 5. Pregnancy 6. Limitation of life support, life expectancy < 7 days or palliative care 7. Allergy to the sleeves material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 04/11/2017: Incidence of proximal leg deep vein thrombosis (DVT) will be followed up to 28 days post randomization. Original primary outcome measure: Incident proximal leg deep vein thrombosis (DVT) will be followed up to 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary and tertiary outcome measure as of 04/11/2017: Secondary outcomes: 1. Pulmonary Embolism: will be followed up to ICU discharge or day 28 2. ICU Mortality. Death in ICU during the same ICU admission 3. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 30-day Mortality: Death before or at day 30 of enrollment. 90-day Mortality: Death before or at day 90 of enrollment Tertiary outcomes: 1. ICU Length of Stay: Number of calendar days between admission and discharge from ICU 2. Duration of Mechanical Ventilation: Number of calendar days between start and end of mechanical ventilation Original secondary and tertiary outcome measures: Secondary outcomes: 1. Pulmonary Embolism: will be followed up to ICU discharge or day 30 2. ICU Mortality. Death in ICU during the same ICU admission 3. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 30-day Mortality: Death before or at day 30 of enrollment. 90-day Mortalit: Death before or at day 90 of enrollment Tertiary outcomes: 1. ICU Length of Stay: Number of calendar days between admission and discharge from ICU 2. Duration of Mechanical Ventilation: Number of calendar days between start and end of mechanical ventilation | — |
Countries
Australia, Brazil, Canada, India, Saudi Arabia
Outcome results
None listed