Clinical trial NCT03061500: Prognostic Value of Proadrenomedullin in Intra-abdominal Sepsis
Official title: Proadrenomedullin as a Severity Score and Prognostic Marker in Intra-abdominal Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraabdominal Infections
Keywords: Proadrenomedullin
Sepsis
Intraabdominal Infections
prognosis
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intraabdominal sepsis patients after damage control surgery

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.

Detailed description: Proadrenomedullin as a Severity Score and Prognostic Marker in Intra-abdominal Sepsis

Research Type:

Prospective, observational study.

Duration:

October 2016 - October 2017

Associated Medical Centers:

La Paz University Hospital (Madrid), La Princesa Hospital (Madrid), Hospital del Mar (Barcelona), Hospital Clínico de Valladolid and Hospital Clínico de Valencia.

Main Goal:

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.

Secondary Goals:

Make a comparison with other biomarkers (procalcitonin, lactic acid, CRP) and clinical severity scales used in standard critical practice (SAPSII, SOFA).

To establish a correlation between the levels of Pro-Adrenomedullin, the time of stay in critical care units, days of mechanical ventilation and mortality.

Variables:

A. Demographics

B. Date of admission to hospital and date of admission to critical care unit unit

C. Clinical data:

* Associated diseases
* SAPS II
* SOFA

D. Intra-abdominal infection episode data

* Systemic response: sepsis / septic shock
* Isolated microorganisms in blood cultures and intra-abdominal fluid
* Complications related to the infectious process (ARDS, need for mechanical ventilation, vasopressors, disseminated intravascular coagulation, acute renal failure, renal replacement techniques)

E. Follow-up

* Critical unit registration date
* Date of discharge from hospital
* Critical unit mortality, in-hospital mortality and 30 days mortality (assessed by telephone contact if the patient had been discharged).

F. Pro-adrenomedullin levels at admission, 24 and 72 hours. As well as procalcitonin (PCT), lactic acid and polymerase Chain Reaction (PCR) levels.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: days of stay in critical units
timeFrame: 30 days
measure: days of mechanical ventilation
timeFrame: 30 days
measure: days of need vasopressors
timeFrame: 30 days
measure: days of need for renal replacement techniques
timeFrame: 30 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.