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recrutment difficulties
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This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Active Comparator | In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg. At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary. |
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| OPTIMIZED | Active Comparator | In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany). The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTROL | Other | In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève | Geneva | Canton of Geneva | 12011 | Switzerland | ||
| Emergency operating room, Geneva Cantonal Hospital |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D014662 | Vasoconstrictor Agents |
| C451741 | point 4 composite resin |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OPTIMIZED | Other | In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI). |
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| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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. |
| 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. |
| Mortality | From randomization up to 28 days |
| SOFA score measurement | From randomization : day 1, day 2, day 3 |
| Death | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first |
| Number of unexpected ICU admission | From randomization up to 28 days |
| Geneva |
| Canton of Geneva |
| 1211 |
| Switzerland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |