Resuscitation Strategies in Septic Shock (ReSSeS). A randomized controlled trial of two different fluid loading strategies in ICU patients with early septic shock.

Completed

Conditions: bloodstream infection
sepsis
10002252

Registration Number: NL-OMON41896

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 170

Inclusion Criteria

1 Age > 18 years
2 Clinical evidence of sepsis (microbiology confirmation, radiological or direct view (pus in biological fluid) or direct surgical view).
3 * 2 SIRS criteria:
a. Temperature < 36.0°C or > 38.0°C
b. Heart rate > 90 bpm
c. Respiratory rate > 20 rpm or PaCO2 < 4.2 kPa or need of mechanical ventilation.
d. Leukocytes > 12.0 x109/L or < 4.0 x109/L or >10% bands
4 Circulatory shock defined as sustained systemic hypotension (systolic arterial pressure <90 mmHg or MAP <65 mmHg (<75 mmHg in a hypertensive patient) despite a 1,000 ml IV fluid challenge over 30 min (including IV fluids administered pre-ICU) or the need for vasopressor therapy. Hypertensive patients are patients with a history of confirmed hypertension treated with antihypertensive agents.
5 Mechanical ventilation by endotracheal tube (any form)

Exclusion Criteria

1 Pregnancy
2 Pre-terminal illness with life expectancy <28 days
3 Duration of circulatory shock >6 hours
4 Severe peripheral arterial vascular occlusion disease (Fontaine level III-IV)
5 Inability for femoral artery canulation
6 No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>VFDs from enrolment to extubation until day 28 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Duration of circulatory shock (consecutive hours on vasopressor therapy).<br /><br><br /><br>Additional Secondary Outcome Measure:<br /><br>1. Daily lung injury scores (LIS) until day 5 after inclusion<br /><br>2. Sequential Organ Failure Assessment (SOFA) until day 28 after inclusion,<br /><br>including organ failure free days.<br /><br>3. Evolution of renal function (RIFLE criteria) during the first 5 days after<br /><br>inclusion and use of renal replacement therapy (RRT)<br /><br>4. Fluid balances during the first 5 days after inclusion<br /><br>5. Length of stay in the ICU<br /><br>6. Hemodynamic parameters to determine efficacy of hemodynamic resuscitation<br /><br>including mean arterial pressure (MAP), central venous pressure (CVP) and<br /><br>central venous oxygen saturation (ScvO2)<br /><br>7. ICU mortality plus 30-days and 90-days mortality<br /><br>8. Microcirculation parameters using SDF imaging</p><br>