MedTrace Logo

Monitoring Resuscitation in Severe Sepsis and Septic Shock

NCT01747057 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 952

Last updated 2014-02-13

No results posted yet for this study

Summary

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.

Conditions

  • Hemodynamics

Interventions

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.

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. 1. PPV \>12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ \[(PPmax+PPmin)/2\] x100 (during 5 respiratory cycles) 2. SVV \> 12% (15). SVV: Stroke volume variation * A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed. 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.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-02-28
Completion
2015-05-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747057 on ClinicalTrials.gov