Monitoring Resuscitation in Severe Sepsis and Septic Shock
|ClinicalTrials.gov Identifier: NCT01747057|
Recruitment Status : Unknown
Verified February 2014 by Antonio Artigas Raventós, Corporacion Parc Tauli.
Recruitment status was: Recruiting
First Posted : December 11, 2012
Last Update Posted : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hemodynamics||Behavioral: Dynamic-parameters-guided fluid management Behavioral: Standard-guided-fluid management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||952 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring Resuscitation in Severe Sepsis and Septic Shock|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||May 2015|
Experimental: Dynamic guide resuscitation
This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management.
Behavioral: Dynamic-parameters-guided fluid management
● 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.
Active Comparator: Standard resuscitation
This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.
Behavioral: Standard-guided-fluid management
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.
- Mortality at 28 days [ Time Frame: 28 days after hospital admission ]
- Length of resuscitation [ Time Frame: 72 hours after protocol inclusion ]
- Vasopressor use and fluid load between 0h to 6h
- Vasopressor use and fluid load between 7h to 72h
- Ventilator-free days [ Time Frame: 28 days after admission ]From 1 to 28 days over 28 days in a month.
- Vasopressor-free days [ Time Frame: 28 days after admission ]From 1 to 28 days over 28 days in a month.
- Organ failure-free days [ Time Frame: 28 days after admission ]Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.
- ICU length of stay [ Time Frame: At ICU discharge (expected average 30 days after admission) ]
- Hospital length of stay [ Time Frame: At hospital discharge (expected average 45 days after hospital admission) ]
- Renal function evolution [ Time Frame: 3 days after study enrollment ]Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).
- Mortality at 3 months [ Time Frame: 3 months after admission ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747057
|Contact: Xaime Garcia, MD||+34937231010 ext email@example.com|
|Contact: Gisela Gili, RN||+34937231010 ext firstname.lastname@example.org|
|Area de Critics. Hospital de Sabadell||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Gemma Goma, RN 937231010 ext 21179 email@example.com|
|Principal Investigator: Xaime Garcia, MD|
|Sub-Investigator: Guillem Gruartmoner, MD|