An observational study in Sepsis, sponsored by Hospital Sao Domingos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Hospital Sao Domingos · Observational
Among 49 studies in Sepsis with a site in Brazil — 4 open to participants now, 6 under way, 1 of them phase 3. Sepsis · Brazil.
Among the 49 studies in Sepsis with a site in Brazil, this one is one of 3 that started in 2021, is one of 9 observational ones, and was the 41st registered.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 160 is close to the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →4 of the 49 studies in Sepsis with a site in Brazil are open now, in 10 countries. Each count lists the studies.
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →49 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2021.
Median enrollment 152 across the 39 interventional studies, 160 across the 9 observational. Of the 35 that completed or were terminated, 4 (11%) have results posted.
9 of 49 have an industry lead sponsor. The 10 most frequent:
Hospital Sao Domingos is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Hospital Sao Domingos has 3 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
1 of the studies in Sepsis with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502794Hospital Israelita Albert EinsteinLong-term Assessment of Patients Treated in the ICU for Sepsis | 2027-06 |
Among the 49 studies in Sepsis with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..
The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.
All critically ill patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days admitted to 3 medical ICUs and 2 surgical ICUs of a tertiary hospital in Brazil.
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.
Included were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November 2022.
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Exclusion Criteria:
We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.
Also known as: Montreal Cognitive Assessment (MoCA), Sinek and young scales
Electroencephalographic patterns
Electroencephalographic patterns determined by Sinek and Young scales. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis. Young's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm \> 50% of record). worst result Suppression The two scales are complementary.
Time frame: 3 months after hospital discharge
Cognitive evaluation
Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)
Time frame: 3 months after hospital discharge
electroencephalographic patterns and 28 days mortality .
Electroencephalographic patterns determined by Sinel and Young scales and 28 days .mortality. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis. Young's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm \> 50% of record). worst result Suppression The two scales are complementary.
Time frame: 28 days
Quality of Life (SF-36) after 3 months of discharge
Quality of life determined through Short-Form Health Survey (SF-36). Scores range from 0 to 100, 0 indicating the less favorable health status and 100 the most favorable one.
Time frame: 3 months after hospital discharge
Plan to share: No
Ran from Nov 2021 to primary completion in Nov 2022, 12 months.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's 12 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Hospital Sao Domingos