The Effect of Recombinant Human Erythropoietin (rHuEPO) on Microcircualtory Alteration in Intensive Care Unit Patients With Severe Sepsis and Septic Shock

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by London Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01087450
First received: March 15, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  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 London Health Sciences Centre:

Estimated Enrollment: 29
Study Start Date: August 2009
Estimated Study Completion Date: March 2011
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Dr. Raymond Kao
ClinicalTrials.gov Identifier: NCT01087450     History of Changes
Other Study ID Numbers: 15474
Study First Received: March 15, 2010
Last Updated: March 15, 2010
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Shock
Shock, Septic
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014