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

January 24, 2017 updated by: Farid Sadaka, MD, Mercy Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients admitted to the Intensive Care Unit with diagnosis of sepsis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Saline
patients with severe sepsis/septic shock randomized to receive 1500 cc of Normal saline bolus as the resuscitation fluid.
Device: Sidestream Dark Field (SDF)

SDF will be applied to the sublingual microvascular network with a 5X objective providing a 167X magnification.

After the removal of saliva and other secretions using gauze, the device will be gently applied (without any pressure) on the lateral side of the tongue, in an area approximately 1.5-4 cm from the tip of the tongue. Five sequences of 20 secs each from different adjacent areas will be recorded using a computer and a video card and stored under a random number for later analysis. This will be done at baseline and then 1 hour after Fluid bolus.

Other Names:
  • SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)
Device: Near Infrared Spectroscopy (NIRS)
Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer, a noninvasive tool, which uses reflectance mode probes to measure scattering light reflected at some distance from where the light is transmitted into the tissue. The NIRS probe will be placed on the skin of the thenar eminence and a sphygmomanometer cuff will be wrapped around the arm over the brachial artery. After a 3-min period to stabilize the NIRS signal, arterial inflow will be stopped (VOT) by inflating the cuff to 50 mmHg above the systolic arterial pressure. After 3 min of ischemia, cuff pressure will be released, and StO2 recorded continuously for another 3 min period (reperfusion period=Reactive Hyperemia).This will be done at baseline and then 1 hour after fluid bolus.
Other Names:
  • NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)
Albumin
patients with severe sepsis/septic shock randomized to receive 500 cc of Albumin 5% bolus as the resuscitation fluid.
Device: Sidestream Dark Field (SDF)

SDF will be applied to the sublingual microvascular network with a 5X objective providing a 167X magnification.

After the removal of saliva and other secretions using gauze, the device will be gently applied (without any pressure) on the lateral side of the tongue, in an area approximately 1.5-4 cm from the tip of the tongue. Five sequences of 20 secs each from different adjacent areas will be recorded using a computer and a video card and stored under a random number for later analysis. This will be done at baseline and then 1 hour after Fluid bolus.

Other Names:
  • SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)
Device: Near Infrared Spectroscopy (NIRS)
Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer, a noninvasive tool, which uses reflectance mode probes to measure scattering light reflected at some distance from where the light is transmitted into the tissue. The NIRS probe will be placed on the skin of the thenar eminence and a sphygmomanometer cuff will be wrapped around the arm over the brachial artery. After a 3-min period to stabilize the NIRS signal, arterial inflow will be stopped (VOT) by inflating the cuff to 50 mmHg above the systolic arterial pressure. After 3 min of ischemia, cuff pressure will be released, and StO2 recorded continuously for another 3 min period (reperfusion period=Reactive Hyperemia).This will be done at baseline and then 1 hour after fluid bolus.
Other Names:
  • NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)
HES
patients with severe sepsis/septic shock randomized to receive 500 cc of Hydroxyethyl starch (HES 130kD) bolus as the resuscitation fluid.
Device: Sidestream Dark Field (SDF)

SDF will be applied to the sublingual microvascular network with a 5X objective providing a 167X magnification.

After the removal of saliva and other secretions using gauze, the device will be gently applied (without any pressure) on the lateral side of the tongue, in an area approximately 1.5-4 cm from the tip of the tongue. Five sequences of 20 secs each from different adjacent areas will be recorded using a computer and a video card and stored under a random number for later analysis. This will be done at baseline and then 1 hour after Fluid bolus.

Other Names:
  • SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)
Device: Near Infrared Spectroscopy (NIRS)
Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer, a noninvasive tool, which uses reflectance mode probes to measure scattering light reflected at some distance from where the light is transmitted into the tissue. The NIRS probe will be placed on the skin of the thenar eminence and a sphygmomanometer cuff will be wrapped around the arm over the brachial artery. After a 3-min period to stabilize the NIRS signal, arterial inflow will be stopped (VOT) by inflating the cuff to 50 mmHg above the systolic arterial pressure. After 3 min of ischemia, cuff pressure will be released, and StO2 recorded continuously for another 3 min period (reperfusion period=Reactive Hyperemia).This will be done at baseline and then 1 hour after fluid bolus.
Other Names:
  • NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculatory perfusion and flow variables
Time Frame: 1 hour after fluid bolus
obtained by Sidestream Dark Field (SDF) microscopy
1 hour after fluid bolus
Muscle tissue oxygenation and oxygen consumption
Time Frame: 1 hour after fluid bolus
using Near Infrared spectroscopy (NIRS)
1 hour after fluid bolus
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
1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Investigators

  • Principal Investigator: Farid G Sadaka, MD, Mercy Hospital St. Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Septic Shock

Clinical Trials on Sidestream Dark Field (SDF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe