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Evaluation of hand microvessel blood flow changes after transient obstruction in patients with infections associated with organ dysfunctions

Evaluation of biomarkers and gene expression profile related to peripheral peripheral microvascular reserve in patients with sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-35tv9ft
Enrollment
Unknown
Registered
2021-05-06
Start date
2020-10-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Total final sample 266 patients. Outcome analyzed was 28-day mortality. Follow-up for 28 days or until discharge. The analyzed groups were composed by all patients with sepsis and its subtypes (sepsis
to evaluate the variations of lactate between groups with high and low peripheral ischemic microvascular reserve throughout the first 48 hours of diagnosis in the context of persistent hyperlactatemia
to evaluate the influence of neuropeptides on ischemic microvascular reserve in patients with sepsis and to analyze ischemic peripheral microvascular reserve as an independent prognostic marker. The i
and taking into account the high incidence of covid among the patients studied (42% of the patients) unexpected when the study was planned - the sample size was increased to 226 patients estimating a
E07.230.740

Sponsors

Complexo hospital de Clínicas da Universidade Federal do Paraná
Lead Sponsor
Instituto Carlos Chagas - Fiocruz
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged greater than or equal to 18 years admitted consecutively to intensive care units with a diagnosis of sepsis and septic shock; patients previously admitted for other causes within 24 hours of onset.

Exclusion criteria

Exclusion criteria: Severe hepatopathy (Child-Pugh class C); Severe coagulopathy (Platelets less than 20,000 and/or activated partial thromboplastin time (APTT) more than 70 seconds and or international normalized ratio (INR) greater than 2); Presence of severe active bleeding; Infective endocarditis; Inaccessible perfusion assessment (severe hypothermia; Raynaud's syndrome, peripheral arterial occlusive disease); Pregnancy; Refusal of the patient to participate in the study.

Design outcomes

Primary

MeasureTime frame
Evaluation of the differences in ischemic microvascular reserve rates between survivors and nonsurvivors of patients with sepsis determined by varying peak perfusion index delta values (%).

Secondary

MeasureTime frame
To evaluate whether peripheral microvascular ischemic reserve maintains its prognostic potential over the first 48 hours of diagnosis in the context of sepsis and septic shock by varying peak perfusion index delta values (%) over the first 48 hours between survivors and non-survivors.;To evaluate the existence of a possible association between ischemic microvascular reserve values and lactate levels and/or variation within the first 48 hours of sepsis diagnosis, by means of peripheral perfusion index delta values (%) and arterial blood lactate levels.;To evaluate the existence of a possible association between ischemic microvascular reserve values with baseline levels and/or percentage change in neuropeptide levels, by means of peripheral perfusion index delta values (%) and pre- and post-test neuropeptide levels.;To evaluate whether ischemic microvascular reserve represents an independent predictor for mortality in sepsis and septic shock, by means of peripheral perfusion index delta values (%).;Assess gene expression in patients with sepsis, using blood levels.

Countries

Brazil

Contacts

Public ContactAna de Miranda

Complexo hospital de Clínicas da Universidade Federal do Paraná

miranda.anacarolina@gmail.com+55 (41) 3360-1800

Outcome results

None listed

Source: REBEC (via WHO ICTRP)