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Proadrenomedullin and Copeptin in Patients With Septic Shock (proADM)

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ClinicalTrials.gov Identifier: NCT03104933
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
José Garnacho Montero, Spanish Network for Research in Infectious Diseases

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.

Condition or disease
Septic Shock

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proadrenomedullin and Copeptin as Predictors of Vasopressor Requirements and Volume Resuscitation in Patients With Septic Shock
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with septic shock
patients in septic shock admitted to the ICU



Primary Outcome Measures :
  1. Levels of proADM and Copeptin as predictors of vasopressor requirements (measured by index inotropic and vasopressor dependency ratio) and fluid requirement [ Time Frame: the first 72 hours. ]

Secondary Outcome Measures :
  1. Levels of proADM and Copeptin as predictors of organ dysfunction [ Time Frame: 28 days ]
  2. Levels of proADM and Copeptin as predictor of 28-day mortality rate [ Time Frame: 28 days ]
  3. Levels of proADM and Copeptin as predictors of lactate clearance [ Time Frame: 6 hours ]

Biospecimen Retention:   Samples Without DNA
Blood Samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with septic shock
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104933


Contacts
Contact: José Garnacho-Montero, MD +349552000 jose.garnacho.sspa@juntadeandalucia.es

Locations
Spain
José Garnacho-Montero Recruiting
Seville, Spain, 41108
Contact: José Garnacho-Montero, MD    +349552000    jose.garnacho.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Spanish Network for Research in Infectious Diseases
Investigators
Principal Investigator: José Garnacho-Montero, MD Hospital Universitario Virgen Macarena

Responsible Party: José Garnacho Montero, MD, Spanish Network for Research in Infectious Diseases
ClinicalTrials.gov Identifier: NCT03104933     History of Changes
Other Study ID Numbers: 0530-N-16
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by José Garnacho Montero, Spanish Network for Research in Infectious Diseases:
Proadrenomedullin
Copeptin
Vasopressors
Septic Shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Diabetes Insipidus
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Adrenomedullin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents