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Clinical Trials/NCT01319630
NCT01319630
Completed
Not Applicable

The Effect of Three Different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients Using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) Analysis

Mercy Research1 site in 1 country45 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Sepsis
Sponsor
Mercy Research
Enrollment
45
Locations
1
Primary Endpoint
Microcirculatory perfusion and flow variables
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Major microvascular blood flow alterations have been documented in patients with severe sepsis. It was also demonstrated that the microcirculation improved in survivors of septic shock but failed to do so in patients dying from acute circulatory failure or with multiple organ failure after shock resolution. Early, effective fluid resuscitation is a key component in the management of patients with severe sepsis and septic shock with the goal of improving tissue perfusion. The best fluid in this early resuscitation phase has been and still is under debate. The aim of this study is to evaluate the effect of Three different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) analysis.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Farid Sadaka, MD

Principal Investigator

Mercy Research

Eligibility Criteria

Inclusion Criteria

  • Adult patients will be enrolled within 24 hrs of onset of severe sepsis/septic shock with an indication for fluid bolus administration.

Exclusion Criteria

  • Liver cirrhosis
  • shock from other causes
  • Oral injuries (precluding SDF imaging)
  • Severe peripheral vascular disease, dialysis fistula, or mastectomies precluding safe forearm occlusion
  • Age \< 18 years

Outcomes

Primary Outcomes

Microcirculatory perfusion and flow variables

Time Frame: 1 hour after fluid bolus

obtained by Sidestream Dark Field (SDF) microscopy

change in microcirculatory and oxygenation variables

Time Frame: 1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables

obtained by both SDF and NIRS

Muscle tissue oxygenation and oxygen consumption

Time Frame: 1 hour after fluid bolus

using Near Infrared spectroscopy (NIRS)

Study Sites (1)

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