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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by St. John's Mercy Research Institute, St. Louis.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01319630
First received: March 18, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Severe Sepsis
Septic Shock
Microcirculation
Device: Sidestream Dark Field (SDF)
Device: Near Infrared Spectroscopy (NIRS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • Microcirculatory perfusion and flow variables [ Time Frame: 1 hour after fluid bolus ] [ Designated as safety issue: No ]
    obtained by Sidestream Dark Field (SDF) microscopy

  • Muscle tissue oxygenation and oxygen consumption [ Time Frame: 1 hour after fluid bolus ] [ Designated as safety issue: No ]
    using Near Infrared spectroscopy (NIRS)

  • change in microcirculatory and oxygenation variables [ Time Frame: 1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables ] [ Designated as safety issue: No ]
    obtained by both SDF and NIRS


Estimated Enrollment: 45
Study Start Date: April 2011
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319630

Contacts
Contact: Farid Sadaka, MD 314-251-6486 farid.sadaka@mercy.net

Locations
United States, Missouri
St. John's Mercy Medical Center Not yet recruiting
St. Louis, Missouri, United States, 63141
Contact: Farid Sadaka, MD    314-251-6486    farid.sadaka@mercy.net   
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
  More Information

No publications provided

Responsible Party: Farid Sadaka, MD, St. John's Mercy Medical Center
ClinicalTrials.gov Identifier: NCT01319630     History of Changes
Other Study ID Numbers: 11-007
Study First Received: March 18, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. John's Mercy Research Institute, St. Louis:
sepsis
microcirculation
saline
crystalloid
colloid
albumin
hydroxyethyl starch

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014