An observational study in Septic Shock, sponsored by Hospital Sao Domingos. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Hospital Sao Domingos · Observational
Among 30 studies in Shock, Septic with a site in Brazil — 4 open to participants now, 4 under way, 4 of them phase 3. Shock, Septic · Brazil.
Among the 30 studies in Shock, Septic with a site in Brazil, this one is one of 2 that started in 2023, is one of 5 observational ones, and was the 27th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 73 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →4 of the 30 studies in Shock, Septic with a site in Brazil are open now, in 10 countries. Each count lists the studies.
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →30 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 2023.
Median enrollment 126 across the 25 interventional studies, 73 across the 5 observational. Of the 21 that completed or were terminated, 2 (10%) have results posted.
3 of 30 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 5 studies filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
2 of the studies in Shock, Septic with a site in Brazil that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07264543Phase 3Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia IntensivaEarly Methylene Blue in the Microhemodynamics of Septic Patients | 2026-11-30 |
| NCT06464510Phase 3Hospital do CoracaoNorepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis | 2027-08 |
Among the 30 studies in Shock, Septic with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This controlled before-and-after study analyse the impact of thiamine supplementation on outcomes of patients with septic shock treated according to the surviving sepsis campaign 2021 guidelines
Vitamin B1 (Thiamine) is a water-soluble vitamin that plays an important role in various biological processes. The active form is thiamine pyrophosphate, an essential cofactor in enzyme systems involved in carbohydrate metabolism and energy production. Recently, the role of thiamine in critically ill patients has gained prominence and septic shock has deserved special attention (1,2). It is important to emphasize that in these situations the clinical syndromes have low sensitivity and specificity for clinical diagnosis, which means that a high level of suspicion must be exercised in these situations. Donnino et al (3) analyzed 88 patients with septic shock in a prospective, randomized, double-blind study. The study showed that the administration of thiamine at a dose of 200 mg every 12 hours for 7 days had a significant impact on mortality only in patients who had reduced serum levels of thiamine. Woolum et al (4 ) retrospectively analyzed the impact of a single dose of Thiamine administered in the 24 hours that preceded the diagnosis of septic shock and compared with patients who did not receive the vitamin and identified improvement in lactate clearance and reduction in 28-day mortality in the thiamine group. Petsakul et al (5) evaluated the effect of thiamine administration in patients with septic shock and need for vasopressors and showed a significant reduction in the vasopressor dose in addition to improvement in lactate clearance. A recent meta-analysis including 5 studies and 645 patients with septic shock analyzed the impact of thiamine use on mortality. The study included 3 prospective randomized studies and 2 retrospective observational studies. The result showed a borderline beneficial effect on mortality. Regarding to HAT (Hydrocortisone, ascorbic acid and thiamine) therapy after the initial study by Marik et al. (7 ) at least 3 prospective randomized studies failed to repeat the good results of the initial study (8,9,10).
The sepsis management protocol at the São Domingos hospital underwent important changes from December 2021 to October 2022. In December, changes were incorporated in the protocol based on the new version of the Surviving Sepsis Campaign 2021 that had been launched the previous month ( 11). In April 2022 the SOSD (salvage, optimization, stabilization and de-resuscitation) systematics (12) was incoporated in the management of septic shock and in October 2022 thiamine use was implemented. Thiamine was incorporated into the protocol, although there are still no robust studies to indicate its use because, despite the implementation of previous measures with exceptional results in sepsis, between January and September 2022, mortality from sepsis was 1.69%, in the septic shock we had evolved little or nothing with mortality in the same period of 70%. In October, thiamine was started in isolated cases and as of November 2022, the investigators started using thiamine systematically and in all cases of septic shock at a dose of 200 mg EV every 12 hours for 7 days. In this controlled before-and-after study, the investigators compared outcomes of patients treated for septic shock between November 2022 and March 2023 with patients diagnosed with septic shock treated between May and September 2022.
This is a retrospective before-after study. Included were all patients with inclusion criteria admitted to a 13-bed surgical ICU, a 12-bed medical and a 12-bed high-complexity surgical and trauma ICU .during the 2 study periods: May 1 to September 30, 2022, control group and November 1, 2022 to March 31, 2023, study group.
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:
Septic shock patients treated according surviving sepsis campaign 2021 guidelines
Septic shock patients treated according surviving sepsis campaign 2021 guidelines supplemented with thiamin 200 mg in 50 ml 5% dextrose twice daily for 7 days.
Drug: Thiamin
Patients in thiamine group received two daily dosis of 200 mg of thiamin diluted in 50 ml of 5% dextrose during 7 days
Compare lactate clearance between intervention (thiamine supplemented) and control group.
Lactate clearance defined as a consistent serum lactate level below 19 mg/dL after the start of treatment for septic shock
Time frame: 30 days
Comparison of mortality rate between intervention (thiamine supplemented) and control
To determine the mortality rate of patients with septic shock who received thiamine supplementation 200 mg twice daily for 7 days (intervention group) compared to a group that did not receive thiamine. Both groups treated according to Surviving Sepsis Campaign guidelines version 2021.
Time frame: 30 days
Comparison of vasopressor-free days during ICU stay between the groups intervention and control
Compare the vasopressor-free days between the two groups during the ICU stay
Time frame: 30 days
Comparison of vantilation-free days during ICU stay between the groups intervention and control
Compare ventilation-free days between the two groups during the ICU stay
Time frame: 30 days
Compare the use of renal replacement therapy, n (%), initiated after 48 hours of septic shock between the groups intervention (thiamine supplementation) and control group
- Compare the use of renal replacement therapy initiated after 48 hours of septic shock between the two groups.
Time frame: 30 days
Plan to share: No
Ran from Sep 2023 to primary completion in Nov 2023, 2 months.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Hospital Sao Domingos