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Proadrenomedullin and Copeptin in Patients With Septic Shock

Proadrenomedullin and Copeptin as Predictors of Vasopressor Requirements and Volume Resuscitation in Patients With Septic Shock

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03104933
Acronym
proADM
Enrollment
103
Registered
2017-04-07
Start date
2016-07-01
Completion date
2021-03-11
Last updated
2021-04-02

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

Conditions

Septic Shock

Keywords

Proadrenomedullin, Copeptin, Vasopressors, Septic Shock

Brief summary

This study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor dependency ratio) and volume requirement for resuscitation.

Detailed description

Physiologically, adrenomedullin has a potent and prolonged vasodilatory effect. In both experimental animals and humans, the intravenous administration of ADM induces a marked and prolonged hypotension. Serum ADM levels are elevated in patients with septic shock. In fact, ADM seems to be one of the main mediators involved in hypotension that these patients present. ADM is not stable in plasma due to its short half-life and rapid binding to receptors. ADM levels can be measured indirectly by determining proadrenomedullin (proADM) which is a more stable molecule and whose levels are reflected in the plasma of ADM. Copeptin is released primarily in response to changes in serum osmolarity or blood volume by increasing peripheral vascular resistance and blood pressure. Copeptin is elevated in patients with shock of different etiologies such as hemorrhagic shock or septic shock. It is not defined in what situations and at what moment an invasive monitoring of the cardiac output and the different hemodynamic variables that reflect the preload and afterload in patients with septic shock should be performed. In fact, there is great variability in the management and treatment of patients with sepsis and septic shock, which includes the selection of patients who require invasive monitoring and the time of onset. Having a biomarker or the combination of biomarkers that allow early determination of which patients will evolve poorly with the development of a shock that requires volume in large quantities and high doses of vasopressors will allow identifying a subgroup of patients that should be performed early hemodynamic monitoring and intensify medical treatment to try to reverse these severe hemodynamic changes.

Interventions

None listed

Sponsors

Spanish Network for Research in Infectious Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ≥ 18 years * Diagnosis of septic shock * Obtaining written informed consent.

Exclusion criteria

* Initial dose of norepinephrine at ICU admission ≥ 0.6 mg / kg / min. * Acute myocardial infarction in the previous month. * History of pituitary surgery. * Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Levels of proADM as predictor of vasopressor requirementsthe first 72 hours.measured by index inotropic and vasopressor dependency ratio) and fluid requirement
Levels o Copeptin as predictor of vasopressor requirements (measured by index inotropic and vasopressor dependency ratio) and fluid requirementthe first 72 hours.measured by index inotropic and vasopressor dependency ratio) and fluid requirement

Secondary

MeasureTime frameDescription
Levels of proADM and Copeptin as predictors of organ dysfunction28 daysSOFA scale
Levels of proADM and Copeptin as predictor of 28-day mortality rate28 daysMortality
Levels of proADM and Copeptin as predictors of lactate clearance6 hoursLactate clearance

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026