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

NCT01319630 | Completed

• 1 other identifier: 11-007
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis; Septic Shock; Microcirculation

Keywords

sepsis; microcirculation; saline; crystalloid; colloid; albumin; hydroxyethyl starch

Outcome Measures

Primary Outcomes (3)

• Microcirculatory perfusion and flow variables

  obtained by Sidestream Dark Field (SDF) microscopy

  1 hour after fluid bolus

• Muscle tissue oxygenation and oxygen consumption

  using Near Infrared spectroscopy (NIRS)

  1 hour after fluid bolus

• change in microcirculatory and oxygenation variables

  obtained by both SDF and NIRS

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

Study Arms (3)

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); Device: Near Infrared Spectroscopy (NIRS)

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); Device: Near Infrared Spectroscopy (NIRS)

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); Device: Near Infrared Spectroscopy (NIRS)

Interventions

Sidestream Dark Field (SDF) DEVICE

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.

Also known as: SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)

Albumin; HES; Normal Saline

Near Infrared Spectroscopy (NIRS) DEVICE

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.

Also known as: NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

Albumin; HES; Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Farid G Sadaka, MD

  Mercy Hospital St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)