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Clinical Trials/NL-OMON41896
NL-OMON41896
Completed
Not Applicable

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

Medisch Spectrum Twente0 sites170 target enrollmentTBD
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Conditionsbloodstream infectionsepsis10002252

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
bloodstream infection
Sponsor
Medisch Spectrum Twente
Enrollment
170
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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