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Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (AdrenOSS-2)

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ClinicalTrials.gov Identifier: NCT03085758
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Adrenomed AG

Brief Summary:
This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

Condition or disease Intervention/treatment Phase
Septic Shock Biological: Adrecizumab Biological: Placebo Phase 2

Detailed Description:

This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

"Early" septic shock is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Early is defined as a maximum of less than 12 hours between onset of the cardiovascular organ-dysfunction and administration of ADRECIZUMAB. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician's assessment of inadequate hemodynamic results.

It is intended to enroll 300 patients from surgical, medical and mixed ICU at multiple centers in Europe.

All patients will be treated according to "International Guidelines for Management of Severe Sepsis and Septic Shock".

Eligible patients (confirmed by central verification) will be randomized (1:1:2) to ADRECIZUMAB treatment arm A (2 mg/kg) or to ADRECIZUMAB treatment arm B (4 mg/kg) or to placebo as control group. Patients assigned to the treatment arm A or B will be administered a single dose of ADRECIZUMAB as intravenous infusion over approximately 1 hour; patients assigned to the control group will be administered placebo as intravenous infusion over approximately 1 hour.

As long as the patients are on the ICU, daily measurements of clinical signs and laboratory data will be collected for safety reasons and for determination of Sequential Organ Failure Assessment Score (SOFA score). Additional blood samples for central laboratory analyses will be taken at inclusion on day 1, day 3, day 5, day 7 or day of discharge (whatever comes first) for measurement of biomarkers.

The SOFA score and its components will be determined daily for all patients over the entire stay on the ICU (28 days or until discharge whatever comes first). Safety monitoring for each patient will begin at the time of signing the Informed Consent Form and continue for 90 days after end of short-term infusion of study medication.

At selected study centers a pharmacokinetic (PK) substudy will be performed to determine the profile of ADRECIZUMAB in 80 randomized patients.

An interim analysis for efficacy is planned after 50% of patients have completed the study (n=150).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind, Placebo-Controlled, Randomized, Multicenter Proof of Concept and Dose-Finding Phase II Clinical Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Treatment Arm A
Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab (treatment arm A)
Biological: Adrecizumab
Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)

Experimental: Treatment Arm B
Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab (treatment arm B)
Biological: Adrecizumab
Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)

Placebo Comparator: Control group
Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab (control group)
Biological: Placebo
Single i.v. dose of placebo (control group)




Primary Outcome Measures :
  1. Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality) [ Time Frame: 90 days ]
    The endpoints for the primary objective are to determine over the 90 days study period: Mortality related to ADRECIZUMAB

  2. Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: interruption of infusion) [ Time Frame: 90 days ]
    The endpoints for the primary objective are to determine over the 90 days study period: Interruption of infusion due to intolerability of ADRECIZUMAB

  3. Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: new treatment emergent AEs) [ Time Frame: 90 days ]
    The endpoints for the primary objective are to determine over the 90 days study period: New treatment-emergent adverse events related to ADRECIZUMAB

  4. Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: severity and frequency of AEs) [ Time Frame: 90 days ]
    The endpoints for the primary objective are to determine over the 90 days study period: Changes in severity and frequency of treatment-emergent adverse events


Secondary Outcome Measures :
  1. Efficacy to be determined by Sepsis Support Index (SSI) [ Time Frame: 14 days ]
    The primary efficacy endpoint of this study is the Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 day follow up More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation, and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow up period is defined as SSI.

  2. Sepsis Support Index (SSI) [ Time Frame: 28 days ]
    Sepsis Support Index (SSI) at 28 day follow-up

  3. Penalized Sepsis Support Index (pSSI) at 14 and 28 day follow-up [ Time Frame: day 14 and day 28 ]
    Penalized Sepsis Support Index (pSSI) at 14 and 28 day follow-up, defined similar to the SSI with the exception that patients that die get penalized by assigning the maximum value, i.e. the pSSI is set to 14 or 28, respectively

  4. Persistent organ dysfunction or death at 14 and 28 day follow-up [ Time Frame: day 14 and day 28 ]
    Persistent organ dysfunction or death at 14 and 28 day follow-up

  5. Mortality Rate [ Time Frame: day 28 and day 90 ]
    Day 28 and day 90 mortality rate

  6. SSI and pSSI excluding the renal component [ Time Frame: 90 days ]
    SSI and pSSI excluding the renal component

  7. Individual Sepsis Support Index components [ Time Frame: 90 days ]
    Individual Sepsis Support Index components (hemodynamic, respiratory and renal failure) with and without mortality

  8. Sequential Organ Failure Assessment (SOFA) Score : Composite measure: SOFA score and its changes over time [ Time Frame: 90 days ]

    Sequential Organ Failure Assessment (SOFA) Score:

    • Mean/maximum/total daily SOFA score during stay at ICU
    • Delta SOFA score, defined as maximum versus minimum SOFA during ICU stay
    • Change in SOFA score within 48 hours
    • SOFA-3 (score limited to cardiovascular, respiratory and renal function)

  9. Improvement in renal function [ Time Frame: day 1, day 3 and day 7 ]
    Improvement in renal function as change in penKid and creatinine (day 3 - day 1, day 7 - day 1)

  10. Length of stay at ICU/ hospital [ Time Frame: 90 days ]
    Length of stay at ICU/ hospital

  11. Changes of functional parameter Mean Arterial Pressure during stay at ICU [ Time Frame: 90 days ]
    Changes of Mean Arterial Pressure (MAP)

  12. Changes of functional parameter creatinine during stay at ICU [ Time Frame: 90 days ]
    Changes of creatinine

  13. Changes of functional Parameter Partial Pressure of Oxygen in Arterial Blood(PaO2) / Fraction of inspired oxygen (FiO2) during stay at ICU [ Time Frame: 90 days ]
    Changes of PaO2/FiO2

  14. Changes of functional Parameter blood lactate during stay at ICU [ Time Frame: 90 days ]
    Changes of blood lactate

  15. Changes of functional Parameter fluid balance during stay at ICU [ Time Frame: 90 days ]
    Changes of fluid balance

  16. Changes of functional Parameter Mid-Regional pro-Adrenomedullin (MR-proADM) during stay at ICU [ Time Frame: 90 days ]
    Changes of MR-proADM

  17. Changes of functional parameter inflammatory marker Procalcitonine (PCT) during stay at ICU [ Time Frame: 90 days ]
    Changes of inflammatory marker PCT

  18. Changes of functional Parameter inflammatory marker Interleukin-6 (IL-6) during stay at ICU [ Time Frame: 90 days ]
    Changes of inflammatory marker IL-6

  19. Vasopressor use [ Time Frame: 90 days ]
    Vasopressor use (drug, highest/lowest dose, duration)

  20. APACHE II score measurement [ Time Frame: 90 days ]
    APACHE II score measurement

  21. Patient reported outcomes : Quality of Life by Euro-QoL-5 [ Time Frame: day 1, day 28 and day 90 ]
    Patient reported outcomes : Quality of Life by Euro-QoL-5 (day 1, day 28 and day 90)

  22. Vital signs [ Time Frame: 90 days ]
    Vital signs (heart rate, blood pressure)


Other Outcome Measures:
  1. In sub-study key Pharmacokinetic Parameters peak plasma concentrations (Cmax) are to be determined in 80 patients [ Time Frame: 28 days ]
    peak plasma concentrations (Cmax) at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after Infusion.

  2. In sub-study key Pharmacokinetic Parameter AUC is to be determined in 80 patients [ Time Frame: 28 days ]
    systemic exposure : Area under the plasma concentration versus time curve (AUC) at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after Infusion.

  3. In sub-study key Pharmacokinetic Parameter volume of distribution is to be determined in 80 patients [ Time Frame: 28 days ]
    volume of distribution (V) at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after Infusion.

  4. In sub-study key Pharmacokinetic Parameter systemic clearance is to be determined in 80 patients [ Time Frame: 28 days ]
    systemic clearance (CL) at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after Infusion.

  5. In sub-study key Pharmacokinetic Parameter Elimination half-life is to be determined in 80 patients [ Time Frame: 28 days ]
    elimination half-life (t½) at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after Infusion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent by patient or legal representative (according to country - specific regulations)
  2. Male and female patient, age ≥ 18 years
  3. Body weight 50 kg - 120 kg
  4. Bio-ADM concentration > 70 pg/ml
  5. Patient with early septic shock (start of vasopressor therapy < 12 hours)

Exclusion Criteria:

  1. Moribund and death is considered imminent< 28 days
  2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all < 3 months), congestive heart failure - New York Heart Association (NYHA) Class IV
  3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment
  4. Severe Chronic Obstructive Pulmonary Disease (COPD) with chronic oxygen need at home (GOLD IV)
  5. Any organ or bone marrow transplant within the past 24 weeks
  6. Uncontrolled serious hemorrhage (≥ 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified
  7. Uncontrolled hematological / oncological malignancies
  8. Immunosuppressed patients (known HIV, absolute neutropenia < 500 per µL)
  9. Treatment with immunosuppressive drugs
  10. Severe chronic liver disease (Child-Pugh C)
  11. Systemic fungal infection or active tuberculosis
  12. Neuromuscular disorders that impact breathing / spontaneous ventilation
  13. Burns > 30% of body surface
  14. Plasmapheresis
  15. Women who are pregnant or nursing
  16. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
  17. Unwilling or unable to be fully evaluated for all follow-up visits -

Information from the National Library of Medicine

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): NCT03085758


Contacts
Contact: Jens Zimmermann, Dr. +49330220 ext 56532 jzimmermann@adrenomed.com
Contact: Kathleen Schmidt +49330220 ext 77817 kschmidt@adrenomed.com

Locations
Belgium
Clinique Universitaire Saint-Luc (UCL Bruxelles) Recruiting
Brussels, Belgium, 1200
Contact: Pierre-Francois Laterre, Prof    : +32 (0)2 764 27 33    pierre-francois.laterre@uclouvain.be   
Contact: Xavier Wittebole, Dr.    +32 (0)2 764 27 26    Xavier.wittebole@uclouvain.be   
Antwerp University Hospital (UZA), Critical Care Medicine Recruiting
Edegem, Belgium, 2650
Contact: Philippe Jorens, Prof    +32 (0) 3 821 36 39    Philippe.jorens@uza.be   
Contact: Karolien Dams, Dr.    +32 (0) 3 821 51 75    karolien.dams@uza.be   
Groupe Jolimont, Hospitalier de Jolimont Recruiting
Haine Saint Paul, Belgium, 7100
Contact: Vincent Huberlant, Dr.    +32 (0) 64 23 49 49    vincent.huberlant@jolimont.be   
Contact: Pierre Henin, Dr.    +32 (0) 64 23 49 49    pierre.henin@jolimont.be   
Clinique St. Pierre, Intensive Care Recruiting
Ottignies, Belgium, 1340
Contact: Thierry Dugernier, Dr.    +32 (0) 10 43 73 43    thierry.dugernier@cspo.be   
Contact: Nicolas De Schryver, Dr.    +32 (0) 10 43 77 34    nicolas.deschryver@cspo.be   
France
Medical Intensive Care Medicine, Centre hospital - universitaire Recruiting
Angers, Cedex, France, 49933
Contact: Pierre Asfar, Dr.    +33 (0)2 41 35 36 37    PiAsfar@chu-angers.fr   
CH Victor Dupouy Recruiting
Argenteuil, Cedex, France, 95107
Contact: Gaetan Plantefeve, Dr.    +33 (0) 1 34 23 14 45    gaetan.plantefeve@ch-argenteuil.fr   
Contact: Hervé Mentec, Dr.    +33 (0) 1 34 23 24 57    herve.mentec@ch-argenteuil.fr   
Hopital Beaujon; Anesthesie Reanimation Recruiting
Clichy, Cedex, France, 92118
Contact: Emmanuel Weiss, Dr.    +33(0) 603 0041 93    emmanuel.weiss@aphp.fr   
Contact: Catherine Paugam-Burtz, Prof    +33(0) 140 87 5911    catherine.paugam@aphp.fr   
CHU de Limoges Recruiting
Limoges, Cedex, France, 87042
Contact: Bruno Francois, Dr.    +33 (0) 555056254    bruno.francois@chu-limoges.fr   
Contact: Philippe Vignon, Dr.    +33 (0) 555058835    philippe.vignon@chu-limoges.fr   
CHU de Nantes; Medicine Intensive Reanimation Recruiting
Nantes, Cedex, France, 44093
Contact: Jean-Baptiste Lascarrou, Dr.    +33 (0)2 4008 7365    jeanbaptiste.lascarrou@chu-nantes.fr   
Contact: Jean Reignier, Prof    +33 (0)2 4008 7369    jean.reignier@chu-nantes.fr   
CHRU Bretonneau, Medecine Intensive Réanimation Recruiting
Tours, Cedex, France, 37044
Contact: Emmanuelle Mercier, Dr.    +33 (0)2 47 47 38 55    emercier@med.univ-tours.fr   
Contact: Pierre Francois Dequin, Dr.    +33 (0)2 47 47 38 55    pierre-francois.dequin@univ-tours.fr   
University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine Recruiting
Clermont-Ferrand, France, 63003
Contact: Jean-Michel Constantin, Prof    +33 (0) 473750541    jmconstantin@chu-clermontferrand.fr   
Contact: Sophie Cayot, Dr.    +33 (0) 73750501    scayot@chu-clermontferrand.fr   
AP-HP, Hopital Louis Mourier, Réanimation Médicale Recruiting
Colombes, France, 92700
Contact: Stéphane Gaudry, Dr.    +33 (0)1 47 60 61 62    stephanegaudry@gmail.com   
Contact: Nicolas Bénichou, Dr.    +33 (0)1 47 60 61 62      
CHD-Vendée Recruiting
La Roche Sur Yon, France, 85000
Contact: Jean-Claude Lacherade, Dr.    +33(0)2 51 44 60 87    jean-claude.lacherade@chd-vendee.fr   
Contact: Gwenhaël Colin, Dr.         
Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Jacques Duranteau, Prof    +33 (0)1 45 21 24 19    Jacques.duranteau@aphp.fr   
Contact: Guillaume Dubreuil, Dr.    +33 (0)1 45 21 24 19    Guillaume.Dubreuil@aphp.fr   
Hôpital Lariboisière, Dept. d'Anesthesie Recruiting
Paris, France, 75010
Contact: Alexandre Mebazaa, Prof    +33 (0)1 4995 8071    Alexandre.mebazaa@aphp.fr   
Contact: Etienne Gayat, Dr.    +33 (0)1 4995 8084    etienne.gayat@aphp.fr   
Hôpital Lariboisière, Réanimation Médicale et Traumatologique Recruiting
Paris, France, 75010
Contact: Nicolas Deye, Dr.    +33 (0)1 49 95 63 47    nicolas.deye@aphp.fr   
Contact: Nicolas Péron, Dr.    +33 (0)1 49 95 90 30    nicolas.peron@aphp.fr   
Hôpital Saint-Louis, Service d'Anesthésie-Réanimation Recruiting
Paris, France, 75010
Contact: Matthieu Legrand, Dr.    +33 (0)1 42 49 94 25    matthieu.legrand@aphp.fr   
Contact: Haikel Oueslati, Dr.    +33 (0)1 42 49 94 25    oueslatihaikel007@yahoo.fr   
Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes Recruiting
Paris, France, 75015
Contact: Romain Pirracchio, Prof    +33 (0)1 56 09 25 13    Romain.pirracchio@aphp.fr   
Nouvel Hopital Civil Recruiting
Strasbourg, France, 67091
Contact: Ferhat Meziani, Prof    +33 (0) 369 5510 21    ferhat.meziani@chru-strasbourg.fr   
Contact: Julie Boisrame-Helms, dr.    +33 (0) 369 5513 69    julie.boisrame-helms@chru-strasbourg.fr   
Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale Recruiting
Strasbourg, France, 67200
Contact: Julien Pottecher, Prof    +33 (0)3 88 12 70 95    julien.pottecher@chru-strasbourg.fr   
Contact: . Jean-Pierre Rameau, Dr.    +33 (0)3 88 12 70 65    jean-pierre.rameau@chru-strasbourg.fr   
Germany
Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin Recruiting
Aachen, Germany, 52074
Contact: Gernot Marx, Prof    +49 (0)241 80 80444    gmarx@ukaachen.de   
Contact: Tim-Philipp Simon, Dr.    +49 (0)241 80 35184    tsimon@ukaachen.de   
Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, Prof    +49 (0)40 7410 57010    s.kluge@uke.de   
Contact: Axel Nierhaus, Dr.    +49 (0)40 7410 57010    nierhaus@uke.de   
Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin Recruiting
Jena, Germany, 07747
Contact: Michael Bauer, Prof    +49 (0)3641 9323101    michael.bauer@med.uni-jena.de   
Contact: Frank Bloos, PD    +49 (0)3641 9323283    frank.bloos@med.uni-jena.de   
Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Recruiting
Muenster, Germany, 48149
Contact: Alexander Zarbock, Prof    +49 (0)251 83 47251    zarbock@uni-muenster.de   
Contact: Thomas Ermert, Dr    +49 (0)251 83 47255    ermert@anit.uni-muenster.de   
Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Recruiting
Rostock, Germany, 18057
Contact: Tobias Schuerholz, Prof    +49 (0)381 494 6481    tobias.schuerholz@med.uni-rostock.de   
Contact: Martin Sauer, PD    +49 (0)381 494 6409    martin.sauer@uni-rostock.de   
Netherlands
Gelderse Vallei Hospital, Department of Intensive Care Recruiting
Ede, Netherlands, 6716 RP
Contact: Arthur van Zanten, Dr.    +31 (0)318 434115    ZantenA@zgv.nl   
Medisch Spectrum Twente, Department of Intensive Care Not yet recruiting
Enschede, Netherlands, 7512 KZ
Contact: Albertus Beishuizen, Dr.    +31 (0)53 48 72 000 ext 7403    b.beishuizen@mst.nl   
Contact: S. Papendorp, Dr.       s.papendorp@mst.nl   
Zuyderland Medical Center, Department of Intensive Care Recruiting
Heerlen, Netherlands, 6401 CX
Contact: Tom Dormans, Dr.    +31 (0)455767220    t.dormans@zuyderland.nl   
Contact: A. Janssen, Dr.    +31 (0) 455767220    g.janssen@zuyderland.nl   
Radboud UMC Intensive Care Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Peter Pickkers, Prof    +31 24 36 65 010    peter.pickkers@radboudumc.nl   
Contact: Hans van der Hoeven, Prof    +31 (0)24 36 14170    Hans.vanderHoeven@radboudumc.nl   
Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care Recruiting
Nijmegen, Netherlands, 6532 SZ
Contact: Oscar Hoiting, Dr.    ++31 (0)24 365 7560    .o.hoiting@cwz.nl   
Sponsors and Collaborators
Adrenomed AG
Investigators
Study Director: Jens Zimmermann, Dr. Adrenomed AG

Responsible Party: Adrenomed AG
ClinicalTrials.gov Identifier: NCT03085758     History of Changes
Other Study ID Numbers: ADR-02
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrenomed AG:
Early Septic Shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Adrenomedullin
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents