Trial record 12 of 256 for:
Open Studies | "Shock"
Discontinuation Order of Vasopressors in Septic Shock (DOVSS)
This study is currently recruiting participants.
Verified December 2011 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Kyeongman Jeon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01493102
First received: December 12, 2011
Last updated: December 14, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.
| Condition | Intervention |
|---|---|
|
Septic Shock |
Drug: Vasopressin Drug: Norepinephrine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Incidence of hypotension [ Time Frame: One hour after dose reduction of vasopressors ] [ Designated as safety issue: Yes ]Hypotension is defined as mean arterial pressure is less than 65mmHg
Secondary Outcome Measures:
- Time of hypotension [ Time Frame: One hour after dose reduction of vasopressors ] [ Designated as safety issue: No ]Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension
- Vasopressor free day [ Time Frame: 28 days after dose reduction of vasopressors ] [ Designated as safety issue: No ]
- 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]All cause mortality within 28 days after hospitalization
- ICU mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]All cause mortlity during ICU admission
- In-hospital mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]All cause mortality during hospitalization
| Estimated Enrollment: | 134 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vasopressin
Vasopressin will be reduced first (0.01 U/hour)
|
Drug: Vasopressin
Vasopressin will be reduced first (0.01 U/hour)
|
|
Active Comparator: Norepinephrine
Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)
|
Drug: Norepinephrine
Norepinephrine will be reduced first (0.1 microgram/kg/hour)
|
Detailed Description:
There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients 20 years of age or older
- patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock
- patients began to reduce the vasopressor
Exclusion Criteria:
- patients who expired or had care withdrawn while receiving norepinephrine and vasopressin
- patients being transferred into the ICU from an outside facility or the operating room
- patients who are suspected to have vasopressin deficiency (eg. HPA axis dysfunction, empty sella)
- acute myocardial infarction or Congestive heart failure (NYHA functional classification III or IV)
- acute mesenteric ischemia
- patients who were received other vasopressor except for norepinephrine or vasopressin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493102
Contacts
| Contact: Kyeongman Jeon, M.D., Ph.D. | 82-3410-3429 | kjeon@skku.edu |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | kyeongman Jeon, M.D., Ph.D. | Samsung Medical Center |
More Information
No publications provided
| Responsible Party: | Kyeongman Jeon, Assistant professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01493102 History of Changes |
| Other Study ID Numbers: | 2011-09-007 |
| Study First Received: | December 12, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
septic shock norepinephrine vasopressin hypotension |
Additional relevant MeSH terms:
|
Shock Shock, Septic Hypotension Vascular Diseases Cardiovascular Diseases Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Vasopressins Arginine Vasopressin Norepinephrine Vasoconstrictor Agents Hemostatics |
Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 21, 2013