Prognostic Value of Proadrenomedullin in Intra-abdominal Sepsis

Intraabdominal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061500
• Other study ID #: PI2289
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2017
• Last updated: February 19, 2017
• Start date: October 15, 2016
• Est. completion date: October 15, 2017

Study information

• Verified date: February 2017
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Ana Maria Montero Feijoo
• Phone: +34696079362
• Email: anamonterofeijoo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Intraabdominal Infections
• Sepsis

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Bello S, Lasierra AB, Mincholé 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. — View 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. Review. — View Citation

Christ-Crain M, Morgenthaler NG, Struck J, Harbarth S, Bergmann A, Müller B. Mid-regional pro-adrenomedullin as a prognostic marker in sepsis: an observational study. Crit Care. 2005;9(6):R816-24. — View Citation

España 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		30 days
Secondary	days of stay in critical units		30 days
Secondary	days of mechanical ventilation		30 days
Secondary	days of need vasopressors		30 days
Secondary	days of need for renal replacement techniques		30 days