TerminatedNot Applicable

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

Stopped: Lack of recruitment

Canada22 participantsStarted 2009-08-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Two or more criteria for the systemic inflammatory response syndrome (SIRS):
. Suspected or confirmed source of infection
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT01087450

SponsorLondon Health Sciences Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-03-07

View on ClinicalTrials.gov More Sepsis trials