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Completed

NCT Number: NCT01319630

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

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Microcirculation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)

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.

Other names: NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

Primary outcomes

  1. Microcirculatory perfusion and flow variables

    Time frame: 1 hour after fluid bolus

    obtained by Sidestream Dark Field (SDF) microscopy

  2. Muscle tissue oxygenation and oxygen consumption

    Time frame: 1 hour after fluid bolus

    using Near Infrared spectroscopy (NIRS)

  3. 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

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Mar 21, 2011
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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