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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319630
• Other study ID #: 11-007
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: January 24, 2017
• Start date: April 2011
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microcirculation
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. John's Mercy Medical Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

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