The Effect of Erythropietin on Microcircualtory Alteration in Intensive Care Unit Patients With Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT01087450|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : March 16, 2010
Last Update Posted : March 13, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||The Effect of rHuEPO on Microcircualtory Alteration in ICU Patients With Severre Sepsis and Septic Shock|
|Actual Study Start Date :||August 12, 2009|
|Actual Primary Completion Date :||March 7, 2018|
|Actual Study Completion Date :||March 7, 2018|
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
- 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 ]
- Semi-quantitative analysis on all images off-line for microcirculatory flow characteristics the units utilized is Percent Perfused Vessel analysis (PPV%)
- It is proposed that with improved PPV% there will be improved venous blood and tissue oxygen saturation.
- 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 ]
- 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.
- Utilizing the In-Spectra monitor model 650 to measure the thenar eminence muscle tissue oxygen saturation or percent saturation.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087450
|London Health Sciences Center-Critical Care Trauma Center|
|London, Ontario, Canada, N6A 5W9|