Intraabdominal InfectionsNCT03061500
Prognostic Value of Proadrenomedullin in Intra-abdominal Sepsis
An observational study of Intraabdominal Infections, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraabdominal Infections
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2016to 15 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intraabdominal sepsis patients after damage control surgery
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating women.
- Patients with neutropenia induced by bone marrow transplant or by chemotherapy (<500 neutrophils / ml).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de la Paz
Madrid, Madrid, 28046
Ana Maria Montero Feijoo, +34696079362, anamonterofeijoo@gmail.com
About this study
Official title: Proadrenomedullin as a Severity Score and Prognostic Marker in Intra-abdominal Sepsis
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.
Read the 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:
- Demographics
- Date of admission to hospital and date of admission to critical care unit unit
- Clinical data:
- Associated diseases
- SAPS II
- SOFA
- 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)
- 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).
- Pro-adrenomedullin levels at admission, 24 and 72 hours. As well as procalcitonin (PCT), lactic acid and polymerase Chain Reaction (PCR) levels.
- Conditions
- Intraabdominal Infections
- Keywords
- Proadrenomedullin, Sepsis, Intraabdominal Infections, prognosis
- Medical subject headings
- Intraabdominal Infections, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30 days
Secondary outcomes (4)
days of stay in critical units
Measured: 30 days
days of mechanical ventilation
Measured: 30 days
days of need vasopressors
Measured: 30 days
days of need for renal replacement techniques
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start15 Oct 2016
- Primary completion15 Oct 2017 (estimated)
- Study completion15 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intraabdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María Montero Fijoo, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061500
- Sponsor's protocol ID
- PI2289
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25499199Bello 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.
PubMed 22075489Cavallazzi 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.
PubMed 25448309Suberviola 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.
PubMed 22430899Christ-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.
PubMed 16356231
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proadrenomedullin as a Severity Score and Prognostic Marker in Intra-abdominal Sepsis
- ClinicalTrials.gov ID
- NCT03061500
- Acronym / sponsor ID
- PI2289
- Conditions
- Intraabdominal Infections
- Keywords
- Proadrenomedullin, Sepsis, Intraabdominal Infections, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 15 Oct 2017 (estimated)
- Study completion
- 15 Oct 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Demographics
- Date of admission to hospital and date of admission to critical care unit unit
- Clinical data:
- Associated diseases
- SAPS II
- SOFA
- 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)
- 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).
- Pro-adrenomedullin levels at admission, 24 and 72 hours. As well as procalcitonin (PCT), lactic acid and polymerase Chain Reaction (PCR) levels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intraabdominal sepsis patients after damage control surgery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or lactating women.
- Patients with neutropenia induced by bone marrow transplant or by chemotherapy (<500 neutrophils / ml).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 30 days
4 secondary outcomes
days of stay in critical units
Time frame: 30 days
days of mechanical ventilation
Time frame: 30 days
days of need vasopressors
Time frame: 30 days
days of need for renal replacement techniques
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 25499199Espana 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.
- Background: PubMed 22075489Bello 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.
- Background: PubMed 25448309Cavallazzi 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.
- Background: PubMed 22430899Suberviola 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.
- Background: PubMed 16356231Christ-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Infections, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Maria Montero Feijoo (+34696079362, anamonterofeijoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061500, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.