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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Raymond Kao, London Health Sciences Centre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01087450
First Posted: March 16, 2010
Last Update Posted: October 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raymond Kao, London Health Sciences Centre
  Purpose
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.

Condition
Sepsis Shock

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effect of rHuEPO on Microcircualtory Alteration in ICU Patients With Severre Sepsis and Septic Shock

Resource links provided by NLM:


Further study details as provided by Raymond Kao, London Health Sciences Centre:

Primary Outcome Measures:
  • Changes in sub-lingual micro-circulatory blood flow for each enrolled subject using the Orthogonal Polarization Spectral imaging at three time points [ Time Frame: 1. Baseline; 2. At 1-hour post treatment with EPO or placebo; 3. At 24-hours post treatment with EPO or placebo ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 1. At baseline 2. 1- hour post treatment or placebo 3. At 24 hors post treatment or placebo ]
    1. Utilizing the blood gas machine in the Intensive Care Unit to measure the splanchnic venous oxygen saturation (SpVo2 or percent saturation) from the venous blood drawn from the femoral central venous catheter.
    2. Utilizing the In-Spectra monitor model 650 to measure the thenar eminence muscle tissue oxygen saturation or percent saturation.
    3. With an improvement of microcirculation in the sub-lingual region there should also be oxygenation saturation improvement in the splanchnic blood pool region and tissue oxygen saturation improvement in the thenar eminence muscle.


Estimated Enrollment: 29
Study Start Date: August 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • The patients must be 18 years old and over to be included in the study. They must meet criteria for sepsis defined as:40

    1. 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.
    2. Suspected or confirmed source of infection

      And either one of the following definitions:

    3. 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
    4. 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087450


Contacts
Contact: Raymond LC Kao, MD 519-685-8500 ext 55662 rkao3@uwo.ca
Contact: Xenocostas Anargyros, MD 519-685-8500 ext 56357 Anargyros.Xenocostas@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Center-Critical Care Trauma Center Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Raymond LC Kao, MD    519-685-8500 ext 55662    rkao3@uwo.ca   
Principal Investigator: Raymond LC Kao, MD         
Sub-Investigator: Martin Claudio, MD         
Sub-Investigator: Anargyros Xenocostas, MD         
Sub-Investigator: Amit Badhwa, PhD         
Sub-Investigator: Neil Parry, MD         
Sub-Investigator: Tao Rui, MD/PhD         
Sub-Investigator: Craig O'Neil, MD         
Sponsors and Collaborators
London Health Sciences Centre
  More Information

Responsible Party: Raymond Kao, Physician, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01087450     History of Changes
Other Study ID Numbers: 15474
First Submitted: March 15, 2010
First Posted: March 16, 2010
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by Raymond Kao, London Health Sciences Centre:
Erythropoietin
Sepsis
Septic shock
Orthogonal Polarization Spectroscopy
Severe sepsis or Septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes