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Trial record 8 of 24 for:    Recruiting, Not yet recruiting, Available Studies | Diabetes insipidus

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 : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
José Garnacho Montero, Spanish Network for Research in Infectious Diseases

Tracking Information
First Submitted Date March 20, 2017
First Posted Date April 7, 2017
Last Update Posted Date June 24, 2019
Study Start Date July 1, 2016
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2017)
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. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03104933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 3, 2017)
  • Levels of proADM and Copeptin as predictors of organ dysfunction [ Time Frame: 28 days ]
  • Levels of proADM and Copeptin as predictor of 28-day mortality rate [ Time Frame: 28 days ]
  • Levels of proADM and Copeptin as predictors of lactate clearance [ Time Frame: 6 hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proadrenomedullin and Copeptin in Patients With Septic Shock
Official Title Proadrenomedullin and Copeptin as Predictors of Vasopressor Requirements and Volume Resuscitation in Patients With 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood Samples
Sampling Method Non-Probability Sample
Study Population Critically ill patients with septic shock
Condition Septic Shock
Intervention Not Provided
Study Groups/Cohorts Patients with septic shock
patients in septic shock admitted to the ICU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: José Garnacho-Montero, MD +349552000 jose.garnacho.sspa@juntadeandalucia.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03104933
Other Study ID Numbers 0530-N-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party José Garnacho Montero, Spanish Network for Research in Infectious Diseases
Study Sponsor Spanish Network for Research in Infectious Diseases
Collaborators Not Provided
Investigators
Principal Investigator: José Garnacho-Montero, MD Hospital Universitario Virgen Macarena
PRS Account Spanish Network for Research in Infectious Diseases
Verification Date June 2019