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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Severe Sepsis, Septic Shock, Microcirculation

Being tested

Sidestream Dark Field (SDF), Near Infrared Spectroscopy (NIRS)

Keywords

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

Medical subject headings

Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Sidestream Dark Field (SDF)Device

  Also called SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands)

  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)Device

  Also called NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Microcirculatory perfusion and flow variables

   obtained by Sidestream Dark Field (SDF) microscopy

   Measured: 1 hour after fluid bolus

2. Muscle tissue oxygenation and oxygen consumption

   using Near Infrared spectroscopy (NIRS)

   Measured: 1 hour after fluid bolus

3. change in microcirculatory and oxygenation variables

   obtained by both SDF and NIRS

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Mar 2011 (estimated)
2. Study startApr 2011
3. Primary completionDec 2013
4. Study completionApr 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Severe SepsisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.