Surgery Clinical Trial
Official title:
Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery A Prospective, Randomised, Open Trial
Verified date | May 2016 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swiss Medic |
Study type | Interventional |
This study compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.
Status | Terminated |
Enrollment | 20 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults > 18 years - Severe hypovolemic condition° - Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min. Exclusion Criteria: - Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC - Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma - Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks) - Sustained cardiac arrhythmia (see Logbook P8) - Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8) - Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8) - Burn injury > 10% - Needed emergency thoracotomy or ABC resuscitation protocol - Pre-existing severe liver dysfunction(Child-Pugh class C) - Do-not-resuscitate order, died within 48h of admission - Ultra-emergent surgery with no further diagnostic investigation. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Switzerland | Hôpitaux universitaires de Genève | Genève |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta lactate | The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (? lactate). | From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours. | No |
Secondary | Cardiovascular complications: myocardial infarct or congestive heart failure | Clinical outcome and surrogate biomarkers (Troponin-I and pro-BNP: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Cerebral complications: stroke | Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Pulmonary complications: ALI/ARDS, bronchopneumonia | Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Pulmonary complications: respiratory insufficiency necessitating re-intubation | Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Surgical complications: re-operation for bleeding or infection | Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Renal complications: infection, urosepsis or renal insufficiency | Clinical outcome and surrogate biomarkers (Riffle score, creatinine: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Duration of post-operative mechanical ventilation: in hours | Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Total duration of ventilation : days | Clinical outcomes (ventilation free days) will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first. | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No |
Secondary | Length of stay in the ICU: in days | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No | |
Secondary | Length of stay in hospital: in days | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No | |
Secondary | Mortality | From randomization up to 28 days | No | |
Secondary | SOFA score measurement | From randomization : day 1, day 2, day 3 | No | |
Secondary | Death | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | No | |
Secondary | Number of unexpected ICU admission | From randomization up to 28 days | No |
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