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Vasopressin Plasma Concentrations in Patients Receiving Exogenous Vasopressin Infusion for Septic Shock

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ClinicalTrials.gov Identifier: NCT03014063
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
This is a prospective observational cohort trial evaluating a single plasma vasopressin concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The trial is designed to determine whether plasma vasopressin concentration influences the likelihood of hemodynamic response to exogenous vasopressin therapy.

Condition or disease
Septic Shock

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vasopressin Plasma Concentrations in Responders and Non-responders to Exogenous Vasopressin Infusion in Patients With Septic Shock
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Vasopressin

Group/Cohort
Hemodynamic responders
Those with a mean arterial pressure of at least 65mmHg and a decrease in catecholamine dose (in norepinephrine equivalents) from initiation of exogenous vasopressin therapy to the time of the sample collection used for analysis of plasma vasopressin concentration
Hemodynamic non-responders
Those without a mean arterial pressure of at least 65mmHg and/or a decrease in catecholamine dose (in norepinephrine equivalents) from initiation of exogenous vasopressin therapy to the time of the sample collection used for analysis of plasma vasopressin concentration



Primary Outcome Measures :
  1. Plasma vasopressin concentration [ Time Frame: 3-6 hours from initiation of exogenous vasopressin administration ]

Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration ]
  2. Catecholamine dose in norepinephrine equivalents [ Time Frame: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration ]
  3. ICU mortality [ Time Frame: Analyzed at ICU discharge, up to 1 year ]
  4. In-hospital mortality [ Time Frame: Analyzed at hospital discharge, up to 1 year ]
  5. Vasopressor-free days [ Time Frame: Day 14 ]
  6. ICU-free days [ Time Frame: Day 14 ]
  7. Acute kidney injury [ Time Frame: Analyzed at ICU discharge, up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with septic shock that are receiving fixed-dose exogenous vasopressin as an adjunct to catecholamines
Criteria

Inclusion Criteria:

  • Patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock
  • Patients ≥18 years of age
  • Treatment with exogenous vasopressin, as ordered by the primary medical team, at a constant infusion rate for at least 3 hours as an adjunctive vasopressor to catecholamine therapy
  • Admission to a medical, surgical, or neurosciences intensive care unit
  • Presence of a central venous catheter or arterial line (as determined by the primary medical team)

Exclusion Criteria:

  • Patients treated with vasopressin for indications other than septic shock
  • Patients administered vasopressin that is titrated within the first 3 hours
  • Patients receiving vasopressin as the sole vasoactive therapy

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): NCT03014063


Contacts
Contact: Jason Yerke, Pharm.D. 216-442-5544 yerkej@ccf.org
Contact: Seth Bauer, Pharm.D. 216-445-2605 bauers@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jason Yerke, Pharm.D.    216-442-5544    yerkej@ccf.org   
Contact: Seth Bauer, Pharm.D.    216-445-2605    bauers@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic

Publications:
Sacha G, Torbic H, Lam S, Bass S, Harinstein L, Welch S, Duggal A, Bauer S. 1355: Predictors of Response to Fixed-Dose Vasopressin in Adult Patients with Septic Shock. Crit Care Med. 2016 Dec;44(12 Suppl 1):414.

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03014063     History of Changes
Other Study ID Numbers: 16-1254
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
sepsis
septic shock
vasopressin
AVP

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs