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The Effect of Three Different Fluids(Albumin 5%, Normal Saline, Hydroxyethyl Starch 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients

M

Mercy Research

Status

Completed

Conditions

Severe Sepsis
Microcirculation
Septic Shock

Treatments

Device: Near Infrared Spectroscopy (NIRS)
Device: Sidestream Dark Field (SDF)

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Normal Saline
Description:
patients with severe sepsis/septic shock randomized to receive 1500 cc of Normal saline bolus as the resuscitation fluid.
Treatment:
Device: Sidestream Dark Field (SDF)
Device: Near Infrared Spectroscopy (NIRS)
Albumin
Description:
patients with severe sepsis/septic shock randomized to receive 500 cc of Albumin 5% bolus as the resuscitation fluid.
Treatment:
Device: Sidestream Dark Field (SDF)
Device: Near Infrared Spectroscopy (NIRS)
HES
Description:
patients with severe sepsis/septic shock randomized to receive 500 cc of Hydroxyethyl starch (HES 130kD) bolus as the resuscitation fluid.
Treatment:
Device: Sidestream Dark Field (SDF)
Device: Near Infrared Spectroscopy (NIRS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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