An observational study in Shock, Sepsis and Hemorrhagic Shock, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 14 studies in Shock by Assistance Publique - Hôpitaux de Paris — 3 open to participants now, 3 under way, none of them phase 3. Shock · Assistance Publique - Hôpitaux de Paris.
Among the 14 studies in Shock by Assistance Publique - Hôpitaux de Paris, this one is one of 2 that started in 2018, is one of 7 observational ones, and was the 6th registered.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →3 of the 14 studies in Shock by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Each count lists the studies.
Of the 68 Shock studies recruiting now, 52 (76%) set no upper age limit and 11 (16%) stop at 75 or younger; 9 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
Median enrollment 38 across the 7 interventional studies, 60 across the 7 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
1 of the studies in Shock by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06384287Assistance Publique - Hôpitaux de ParisPeripheral Tissue Perfusion in Intensive Care | 2027-07 |
Among the 14 studies in Shock by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided on hemodynamic macrovascular parameters. Analysis of sublingual microcirculation in shock patients is predictive of mortality and organ dysfunction. To optimize the quality of the resuscitation in shock patients, it could be useful to have an assessment of sublingual microcirculation in addition to the macrovascular parameters usually assessed by the nurses. But, this requires to have a monitor of sublingual microcirculation easy to use and to analyze at the bedside.
The primary outcome of the present study is to test the ability of visual analysis of sublingual microcirculation by nurses to predict needs for fluid challenge, vasopressors or transfusion in patients in shock. After ICU admission and study inclusion, the nurses in charge of the patient will perform a set of measurements of macrocirculatory and microcirculatory parameters every 4 h during the first three days after ICU admission and before and after every hemodynamic therapeutic intervention, such as fluid challenge, transfusion of red blood cells or change in catecholamine rate.
The secondary outcomes are to test 1/ to test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction (SOFA score), and 2/ to evaluate the relationship between hemodynamic macrovascular and microvascular parameters. Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)) will be included. In addition, patients will be included only when patients will obviously stay more than 24 hours in the ICU.
In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided on hemodynamic macrovascular parameters as arterial pressure, cardiac output, lactate and diuresis. Analysis of sublingual microcirculation in shock patients is predictive of mortality and organ dysfunction. To optimize the quality of the resuscitation in shock patients, it could be useful to have an assessment of sublingual microcirculation in addition to the macrovascular parameters usually assessed by the nurses. But, this requires to have a monitor of sublingual microcirculation easy to use and to analyze at the bedside. In a previous study, using a side-stream dark-field (SDF) imaging device (Cytocam video microscope, Braedius®, Netherlands), the investigators have reported that a real-time nurse bedside qualitative evaluation of Microvascular flow index (MFI) had a good agreement with conventional delayed physician analysis, and was highly sensitive and specific for detecting impaired microvascular flow and low capillary density.
The primary outcome of the present study is to test the ability of visual analysis of sublingual microcirculation by nurses in patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
The secondary outcomes are:
Study design and measurements After ICU admission and study inclusion, the nurses in charge of the patient will perform a set of measurements of macrocirculatory and microcirculatory parameters every 4 h during the first three days after ICU admission and before and after every hemodynamic therapeutic intervention, such as fluid challenge, transfusion of red blood cells or change in catecholamine rate during this period.
Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
Other: Patients in shock
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
Measured of Microvascular Flow Index (MFI)
Each set of measurements will consist of three successive video sequences of 20 seconds at three different sites. The nurse will calculate the MFI score. The image will be divided into 4 quadrants and the vessels \<20 μm diameter will be assigned a score based on the predominant flow characteristics of the vessels in that quadrant (0 = absent flow; 1 = intermittent; 2 = sluggish; 3 = normal). The values in each quadrant are averaged to give an MFI score for each sublingual site at each time point
Time frame: Every 4 hours during 3 days
SOFA score
To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction
Time frame: Every 4 hours during 3 days
Hemodynamic macrovascular parameters
To evaluate the relationship between hemodynamic macrovascular and microvascular parameters. We will consider the macrovascular parameters usually collected by nurses each 4h: arterial pressure, heart rate, cardiac index, stroke volume index, global end-diastolic blood volume, extravascular lung water, the respiratory variations of pulse pressure (delta PP), lactate, hemoglobin, venous-to-arterial carbon dioxide differences (Pv-aCO2), diuresis and the microvascular parameters (MFI and capillary density)
Time frame: Every 4 hours during 3 days
Hemodynamic microvascular parameters.
To evaluate the relationship between hemodynamic macrovascular and microvascular parameters. We will consider the macrovascular parameters usually collected by nurses each 4h: arterial pressure, heart rate, cardiac index, stroke volume index, global end-diastolic blood volume, extravascular lung water, the respiratory variations of pulse pressure (delta PP), lactate, hemoglobin, venous-to-arterial carbon dioxide differences (Pv-aCO2), diuresis and the microvascular parameters (MFI and capillary density)
Time frame: Every 4 hours during 3 days
Plan to share: No
Started Mar 2018 (actual). Primary completion is estimated for Oct 2021, 43 months after the start.
Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 43 months is above that.
Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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