Overview

This trial is active, not recruiting.

Condition septic shock
Sponsor Beth Israel Deaconess Medical Center
Collaborator Hutchinson Technologies
Start date September 2008
End date September 2016
Trial size 300 participants
Trial identifier NCT01062685, 2008-000323

Summary

The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Non-infected controls that are age and sex matched on a 1:1 basis with the septic shock cohort.

Primary Outcomes

Measure
Organ Dysfunction and Severity of Illness
time frame: time 0 - 24 hrs

Secondary Outcomes

Measure
Mortality
time frame: In hospital

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: There will be three cohorts enrolled in this study- A. Septic Shock Cohort (n=60) Inclusion criteria: 1. Suspected infection 2. Any two of four criteria of systemic inflammatory response: 1. Temperature > 100.4° or < 96.8° F 2. Heart rate > 90 beats/minute 3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg 4. WBC >12,000 or < 4000 cells/µL or > 10% bands 3. Evidence of hypoperfusion evidenced by either of the following: 1. SBP < 90 mm Hg after 20cc/kg crystalloid 2. a whole blood lactate > 4 mmol/L 3. vasopressor use Exclusion criteria: 1. Age < 18 years 2. Pregnancy 3. Acute traumatic or burn injury (primary diagnosis) 4. Acute cerebrovascular event (primary diagnosis) 5. Acute coronary syndrome (primary diagnosis) 6. Acute pulmonary edema (primary diagnosis) 7. Cardiac dysrhythmia (primary diagnosis) 8. Acute and active gastrointestinal bleeding (primary diagnosis) 9. Acute drug overdose (primary diagnosis) 10. Requirement for immediate surgery B. Sepsis Cohort (n=60) Inclusion Criteria: 1. Suspected infection 2. Any two of four criteria of systemic inflammatory response: 1. Temperature > 100.4° or < 96.8° F 2. Heart rate > 90 beats/minute 3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg 4. WBC >12,000 or < 4000 cells/µL or > 10% bands 3. NO Evidence of hypoperfusion evidenced by either of the following: 1. SBP < 90 mm Hg after 20cc/kg crystalloid 2. a whole blood lactate > 4 mmol/L Exclusion Criteria: per above for septic shock cohort C. Pre-Shock Cohort (n=60) Inclusion Criteria: 1. Suspected or confirmed infection as primary reason for admission 2. Serum Lactate ≥2.0 and <4.0 mmol/L OR any SBP < 90 mmHg and now > 100mmHg 3. Hospital admission planned 4. Identification within 3 hours of lactate measurement or hypotension Exclusion Criteria: 1. Age < 18 years 2. Pregnancy 3. Evidence of Overt Shock/Hypoperfusion upon enrollment: - Serum lactate ≥ 4.0 mmol/L - Any vasopressor or inotrope use 4. Mechanical ventilation before enrollment 5. Acute traumatic or burn injury 6. Acute cerebrovascular event 7. Acute coronary syndrome 8. Acute pulmonary edema 9. Acute and active gastrointestinal bleeding 10. Requirement for immediate surgery 11. Inability to obtain written informed consent 12. Known reported stable systolic blood pressure < 100 mmHg 13. Patient not eligible for vasopressor therapy (e.g. advanced directives) D. Non-infected Controls (n=40) Inclusion Criteria: 1. No Suspected infection 2. Absence of any systemic inflammatory response criteria: 1. Temperature > 100.4° or < 96.8° F 2. Heart rate > 90 beats/minute 3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg 4. WBC >12,000 or < 4000 cells/µL or > 10% bands 3. NO Evidence of hypoperfusion evidenced by absence of either of the following: 1. SBP < 90 mm Hg after 20cc/kg crystalloid 2. a whole blood lactate > 4 mmol/L Non-infected controls will be age and sex matched on a 1:1 basis with the septic shock cohort. Exclusion Criteria: per above criteria for septic shock cohort

Additional Information

Official title Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)
Principal investigator Nathan I Shapiro, MD, MPH
Description Near Infrared Spectroscopy (NIRS) can be utilized to measure tissue oxygenation, offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving. Three distinct ways to measure StO2 have been proposed: 1) initial random spot-check measurements (StO2 initial); 2) minimum value over a 3-hour observation period (StO2 min); and, 3) changes in StO2 in response to an ischemic challenge (change in StO2 and StO2 slope). The purpose of this study is to assess the diagnostic ability of each of these parameters to predict morbidity, mortality, and resource utilization. This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.