Proadrenomedullin and Copeptin in Patients With Septic Shock (proADM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03104933|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : September 13, 2018
|Condition or disease|
Physiologically, adrenomedullin has a potent and prolonged vasodilatory effect. In both experimental animals and humans, the intravenous administration of ADM induces a marked and prolonged hypotension. Serum ADM levels are elevated in patients with septic shock. In fact, ADM seems to be one of the main mediators involved in hypotension that these patients present.
ADM is not stable in plasma due to its short half-life and rapid binding to receptors. ADM levels can be measured indirectly by determining proadrenomedullin (proADM) which is a more stable molecule and whose levels are reflected in the plasma of ADM.
Copeptin is released primarily in response to changes in serum osmolarity or blood volume by increasing peripheral vascular resistance and blood pressure.
Copeptin is elevated in patients with shock of different etiologies such as hemorrhagic shock or septic shock.
It is not defined in what situations and at what moment an invasive monitoring of the cardiac output and the different hemodynamic variables that reflect the preload and afterload in patients with septic shock should be performed. In fact, there is great variability in the management and treatment of patients with sepsis and septic shock, which includes the selection of patients who require invasive monitoring and the time of onset.
Having a biomarker or the combination of biomarkers that allow early determination of which patients will evolve poorly with the development of a shock that requires volume in large quantities and high doses of vasopressors will allow identifying a subgroup of patients that should be performed early hemodynamic monitoring and intensify medical treatment to try to reverse these severe hemodynamic changes.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Proadrenomedullin and Copeptin as Predictors of Vasopressor Requirements and Volume Resuscitation in Patients With Septic Shock|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Patients with septic shock
patients in septic shock admitted to the ICU
- Levels of proADM and Copeptin as predictors of vasopressor requirements (measured by index inotropic and vasopressor dependency ratio) and fluid requirement [ Time Frame: the first 72 hours. ]
- Levels of proADM and Copeptin as predictors of organ dysfunction [ Time Frame: 28 days ]
- Levels of proADM and Copeptin as predictor of 28-day mortality rate [ Time Frame: 28 days ]
- Levels of proADM and Copeptin as predictors of lactate clearance [ Time Frame: 6 hours ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104933
|Contact: José Garnacho-Montero, MDemail@example.com|
|Seville, Spain, 41108|
|Contact: José Garnacho-Montero, MD +349552000 firstname.lastname@example.org|
|Principal Investigator:||José Garnacho-Montero, MD||Hospital Universitario Virgen Macarena|