Septic ShockDOVSSNCT01493102
Discontinuation Order of Vasopressors in Septic Shock
A study testing Vasopressin and Norepinephrine in people with Septic Shock, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Vasopressin and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who expired or had care withdrawn while receiving norepinephrine and vasopressin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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Vasopressin, Norepinephrine
- Keywords
- septic shock, norepinephrine, vasopressin, hypotension
- Medical subject headings
- Shock, Septic, Diabetes Insipidus, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Vasopressin will be reduced first (0.01 U/hour)
NorepinephrineDrug
Norepinephrine will be reduced first (0.1 microgram/kg/hour)
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Active comparator | Vasopressin will be reduced first (0.01 U/hour) Receives: Drug: Vasopressin |
| Norepinephrine | Active comparator | Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour) Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Hypotension is defined as mean arterial pressure is less than 65mmHg
Measured: One hour after dose reduction of vasopressors
Secondary outcomes (5)
Time of hypotension
Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension
Measured: One hour after dose reduction of vasopressors
Vasopressor free day
Measured: 28 days after dose reduction of vasopressors
28-day mortality
All cause mortality within 28 days after hospitalization
Measured: 28 days
ICU mortality
All cause mortlity during ICU admission
Measured: 3 months
In-hospital mortality
All cause mortality during hospitalization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Futility by interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyeongman Jeon, Samsung Medical Center
- Investigators
- kyeongman Jeon, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493102
- Sponsor's protocol ID
- 2011-09-007
- Acronym
- DOVSS
- Status last verified
- Jan 2015
- First submitted
- 12 Dec 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
PubMed 29784057
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock
- ClinicalTrials.gov ID
- NCT01493102
- Acronym / sponsor ID
- DOVSS / 2011-09-007
- Conditions
- Septic Shock
- Keywords
- septic shock, norepinephrine, vasopressin, hypotension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility by interim analysis
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Dec 2011 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin | Active comparator | Drug: VasopressinVasopressin will be reduced first (0.01 U/hour) |
| Norepinephrine | Active comparator | Drug: NorepinephrineNorepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinVasopressin will be reduced first (0.01 U/hour) | Drug | Vasopressin |
| NorepinephrineNorepinephrine will be reduced first (0.1 microgram/kg/hour) | Drug | Norepinephrine |
Primary outcome
Incidence of hypotension
Time frame: One hour after dose reduction of vasopressors
Hypotension is defined as mean arterial pressure is less than 65mmHg
5 secondary outcomes
Time of hypotension
Time frame: One hour after dose reduction of vasopressors
Vasopressor free day
Time frame: 28 days after dose reduction of vasopressors
28-day mortality
Time frame: 28 days
ICU mortality
Time frame: 3 months
In-hospital mortality
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Futility by interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 29784057Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
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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.
kyeongman Jeon, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasopressin and Norepinephrine in people with Septic Shock, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Jan 2015. 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 South Korea. 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?
The study was stopped early (reason given: Futility by interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: One hour after dose reduction of vasopressors). 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 NCT01493102, which also lists 1 linked publication.
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 30 Jan 2015.