NCT03061500

Brief Summary

An observational, prospective study whose main objective is to measure the value of Pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with intra-abdominal sepsis after damage control surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 19, 2017

Last Update Submit

February 19, 2017

Conditions

Keywords

ProadrenomedullinSepsisIntraabdominal Infectionsprognosis

Outcome Measures

Primary Outcomes (1)

  • mortality

    30 days

Secondary Outcomes (4)

  • days of stay in critical units

    30 days

  • days of mechanical ventilation

    30 days

  • days of need vasopressors

    30 days

  • days of need for renal replacement techniques

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intraabdominal sepsis patients after damage control surgery

You may qualify if:

  • All patients consecutively collected, adults over 18, who are admitted to critical care unit with the diagnosis of localized or generalized intraabdominal infection after damage control surgery.

You may not qualify if:

  • Pregnant or lactating women.
  • Patients with neutropenia induced by bone marrow transplant or by chemotherapy (\<500 neutrophils / ml).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (5)

  • Espana PP, Capelastegui A, Mar C, Bilbao A, Quintana JM, Diez R, Esteban C, Bereciartua E, Unanue U, Uranga A. Performance of pro-adrenomedullin for identifying adverse outcomes in community-acquired pneumonia. J Infect. 2015 May;70(5):457-66. doi: 10.1016/j.jinf.2014.12.003. Epub 2014 Dec 11.

    PMID: 25499199BACKGROUND
  • Bello S, Lasierra AB, Minchole E, Fandos S, Ruiz MA, Vera E, de Pablo F, Ferrer M, Menendez R, Torres A. Prognostic power of proadrenomedullin in community-acquired pneumonia is independent of aetiology. Eur Respir J. 2012 May;39(5):1144-55. doi: 10.1183/09031936.00080411. Epub 2011 Nov 10.

    PMID: 22075489BACKGROUND
  • Cavallazzi R, El-Kersh K, Abu-Atherah E, Singh S, Loke YK, Wiemken T, Ramirez J. Midregional proadrenomedullin for prognosis in community-acquired pneumonia: a systematic review. Respir Med. 2014 Nov;108(11):1569-80. doi: 10.1016/j.rmed.2014.09.018.

    PMID: 25448309BACKGROUND
  • Suberviola B, Castellanos-Ortega A, Llorca J, Ortiz F, Iglesias D, Prieto B. Prognostic value of proadrenomedullin in severe sepsis and septic shock patients with community-acquired pneumonia. Swiss Med Wkly. 2012 Mar 19;142:w13542. doi: 10.4414/smw.2012.13542. eCollection 2012.

    PMID: 22430899BACKGROUND
  • Christ-Crain M, Morgenthaler NG, Struck J, Harbarth S, Bergmann A, Muller B. Mid-regional pro-adrenomedullin as a prognostic marker in sepsis: an observational study. Crit Care. 2005;9(6):R816-24. doi: 10.1186/cc3885. Epub 2005 Nov 15.

    PMID: 16356231BACKGROUND

MeSH Terms

Conditions

Intraabdominal InfectionsSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ana Maria Montero Feijoo

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2017

First Posted

February 23, 2017

Study Start

October 15, 2016

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations