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Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.
To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic guide resuscitation | Experimental | This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management. |
|
| Standard resuscitation | Active Comparator | This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic-parameters-guided fluid management | Behavioral | ● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation* and with sinus rhythm.
Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV < 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP>12). ● Non-preload responsive patients (defined as PPV or SVV < 12%) will resume the same protocol as responders when fluid response parameters are negative. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 days | 28 days after hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Length of resuscitation |
| 72 hours after protocol inclusion |
| Ventilator-free days | From 1 to 28 days over 28 days in a month. |
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Inclusion Criteria:
Age > 18 years
Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
≥ 2 SIRS criteria:
Hemodynamic insufficiency defined as (at least one of the following):
Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O.
Prior hemodynamic monitoring by arterial catheter.
Central venous catheter.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xaime Garcia, MD | Contact | +34937231010 | 21156 | xgarcia@tauli.cat |
| Gisela Gili, RN | Contact | +34937231010 | 21159 | ggilis@tauli.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Area de Critics. Hospital de Sabadell | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| Standard-guided-fluid management | Behavioral | Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (> 65mmHg) or CVP > 12mmHg. If CVP reaches > 12 mmHg and MAP remains < 65mmHg, norepinephrine should be started to reach MAP > 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output < 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning. |
|
| 28 days after admission |
| Vasopressor-free days | From 1 to 28 days over 28 days in a month. | 28 days after admission |
| Organ failure-free days | Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month. | 28 days after admission |
| ICU length of stay | At ICU discharge (expected average 30 days after admission) |
| Hospital length of stay | At hospital discharge (expected average 45 days after hospital admission) |
| Renal function evolution | Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula). | 3 days after study enrollment |
| Mortality at 3 months | 3 months after admission |