Prognostic Value of Proadrenomedullin in Intra-abdominal Sepsis

• Conditions: Intraabdominal Infections

• Registration Number: NCT03061500
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2016-10-15
• Status Verified: 2017-02
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-19
• Last Update Submitted: 2017-02-19
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-10-15
• Study Completion: 2017-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	30 days

Secondary Outcome Measures

Name	Time	Method
days of need for renal replacement techniques	30 days
days of mechanical ventilation	30 days
days of stay in critical units	30 days
days of need vasopressors	30 days

Trial Locations

Locations (1)

Hospital Universitario de la Paz; 🇪🇸 Madrid, Spain