Proadrenomedullin and Copeptin in Patients With Septic Shock

NCT03104933 | Completed

• 1 other identifier: 0530-N-16
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Proadrenomedullin; Copeptin; Vasopressors; Septic Shock

Outcome Measures

Primary Outcomes (2)

• Levels of proADM as predictor of vasopressor requirements

  measured by index inotropic and vasopressor dependency ratio) and fluid requirement

  the first 72 hours.

• Levels o Copeptin as predictor of vasopressor requirements (measured by index inotropic and vasopressor dependency ratio) and fluid requirement

  measured by index inotropic and vasopressor dependency ratio) and fluid requirement

  the first 72 hours.

Secondary Outcomes (3)

• Levels of proADM and Copeptin as predictors of organ dysfunction

  28 days

• Levels of proADM and Copeptin as predictor of 28-day mortality rate

  28 days

• Levels of proADM and Copeptin as predictors of lactate clearance

  6 hours

Study Arms (1)

Patients with septic shock

patients in septic shock admitted to the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with septic shock

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Spanish Network for Research in Infectious Diseases: lead

Study Sites (1)

José Garnacho-Montero

Seville, 41108, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

MeSH Terms

Conditions

Shock, Septic; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• José Garnacho-Montero, MD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 7, 2017
• Study Start: July 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: March 11, 2021
• Last Updated: April 2, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)