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

NCT ID: NCT01319630

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-04-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal Saline

patients with severe sepsis/septic shock randomized to receive 1500 cc of Normal saline bolus as the resuscitation fluid.

Sidestream Dark Field (SDF)

Intervention Type: 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.

Near Infrared Spectroscopy (NIRS)

Intervention Type: 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.

Albumin

patients with severe sepsis/septic shock randomized to receive 500 cc of Albumin 5% bolus as the resuscitation fluid.

Sidestream Dark Field (SDF)

Intervention Type: 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.

Near Infrared Spectroscopy (NIRS)

Intervention Type: 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.

HES

patients with severe sepsis/septic shock randomized to receive 500 cc of Hydroxyethyl starch (HES 130kD) bolus as the resuscitation fluid.

Sidestream Dark Field (SDF)

Intervention Type: 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.

Near Infrared Spectroscopy (NIRS)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

SDF ((Microscan; Microvision Medical, Amsterdam, the Netherlands); NIRS (InSpectra Model 650, Hutchinson Technology, Hutchinson, Minn.)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Farid Sadaka, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farid G Sadaka, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital St. Louis

Locations

St. John's Mercy Medical Center

St Louis, Missouri, United States

Countries

United States

Other Identifiers

11-007

Identifier Type: -

Identifier Source: org_study_id