The Effect of Erythropietin on Microcircualtory Alteration in Intensive Care Unit Patients With Severe Sepsis

NCT01087450 | Terminated DMC

• 1 other identifier: 15474
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if observations the investigators made in an animal model of sepsis can be translated to clinical practice. Specifically, the investigators will use the noninvasive Orthogonal Polarization Spectral (OPS) microscope and venous oxygen saturation to test the hypothesis that recombinant human erythropoietin(rHuEPO) will acutely improve the microcircualtion in septic patients in the ICU.

Conditions

Sepsis; Shock

Keywords

Erythropoietin; Sepsis; Septic shock; Orthogonal Polarization Spectroscopy; Severe sepsis or Septic shock

Outcome Measures

Primary Outcomes (1)

• Changes in sub-lingual micro-circulatory blood flow for each enrolled subject using the Orthogonal Polarization Spectral imaging at three time points

  1. Semi-quantitative analysis on all images off-line for microcirculatory flow characteristics the units utilized is Percent Perfused Vessel analysis (PPV%) 2. It is proposed that with improved PPV% there will be improved venous blood and tissue oxygen saturation.

  1. Baseline; 2. At 1-hour post treatment with EPO or placebo; 3. At 24-hours post treatment with EPO or placebo

Secondary Outcomes (1)

• 1. Changes in splanchnic venous oxygen saturation at three time points for each subject. 2. Changes in tissue oxygen saturation of the thenar eminence muscle at three time points for each subject.

  1. At baseline 2. 1- hour post treatment or placebo 3. At 24 hors post treatment or placebo

Study Arms (2)

Stage1

1\. Prospective dose response group. 3 subjects per dose at 200U/kg, 400U/kg and 600U/kg rHuEPO

Stage 2 Randomized, blinded trial

Control group: Randomized to placebo treatment Treatment Group: Randomized to rHuEPO treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruitment Critical Care research coordinators and a Research Fellow will screen patients for severe sepsis and septic shock in the London Health Sciences Center-Critical Care Trauma Center (LHSC-CCTC). The patients who meet the inclusion criteria will be introduced to this study. Informed consent will be obtained from the patient or a family member or a substitute decision maker.

You may qualify if:

• The patients must be 18 years old and over to be included in the study. They must meet criteria for sepsis defined as:40
• Two or more criteria for the systemic inflammatory response syndrome (SIRS):
• heart rate greater than 90 beats per minute, or paced, or taking beta-blockers or the calcium channel blockers verapamil or diltiazem
• respiratory rate greater than 20 breathes per minute, or a PaC02 less than 32 mmHg, or mechanically ventilated
• temperature greater than 38 or less than 36 degrees Celsius
• white blood cell count greater than 12 x 109/L or less than 4 x 109/L, or more than 10% bands on the differential.
• Suspected or confirmed source of infection
• And either one of the following definitions:
• Severe Sepsis: Sepsis with at least one organ dysfunction defined as urine output \< 0.5 ml/kg/hr for 1 hour, PaO2/FiO2 \< 250 (less than 200 if lung is the only dysfunctional organ), platelets \< 80 x109/L or a 50% decrease from baseline in the past 3 days, or pH \< 7.30 or lactate \> 1.5 mmole/L upper normal with base deficit \> 5
• Septic shock \<48hrs: Persistent arterial hypotension with a systolic pressure \< 90 mmHg or a MAP \< 60 mmHg or a reduction of in systolic blood pressure \> 40 mmHg from baseline, despite adequate fluid resuscitation in the absence of other cause for hypotension or requiring the administration of a pressor agent to maintain the above blood pressure.

You may not qualify if:

• Clinically apparent other forms of shock including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax) or hemorrhagic shock
• A known previous severe reaction to erythropoietin
• Uncontrolled hypertension (hypertensive urgency, hypertensive emergency and hypertensive encephalopathy)
• Myocardial infarction and/or stroke within one month
• Hypersensitivity reaction after previous rh-EPO use. Known sensitivity to products from mammalian cell cultures
• Previous history of deep venous thromboses or pulmonary embolism
• Burns
• Cirrhosis
• Traumatic brain injury
• Less than 18 years of age
• Family or patient not committed to aggressive care
• Currently enrolled in another related interventional study
• Any active cancer patients of any type and stage except for patients with basal and squamous cell skin cancers
• Patient weighing \> 100 kg

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Center-Critical Care Trauma Center

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Sepsis; Shock; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: August 12, 2009
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

CA (1)