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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03061500
Study type Observational
Source Instituto de Investigación Hospital Universitario La Paz
Contact Ana Maria Montero Feijoo
Phone +34696079362
Email anamonterofeijoo@gmail.com
Status Recruiting
Phase N/A
Start date October 15, 2016
Completion date October 15, 2017

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