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

Completed

• Conditions: Septic Shock; Microcirculation; Severe Sepsis
• Interventions: Device: Sidestream Dark Field (SDF); Device: Near Infrared Spectroscopy (NIRS)

• Registration Number: NCT01319630
• Lead Sponsor: Mercy Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Microcirculatory perfusion and flow variables	1 hour after fluid bolus	obtained by Sidestream Dark Field (SDF) microscopy
change in microcirculatory and oxygenation variables	1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables	obtained by both SDF and NIRS
Muscle tissue oxygenation and oxygen consumption	1 hour after fluid bolus	using Near Infrared spectroscopy (NIRS)

Trial Locations

Locations (1)

St. John's Mercy Medical Center; 🇺🇸 St. Louis, Missouri, United States