NCT01493102

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

December 12, 2011

Last Update Submit

January 28, 2015

Conditions

Septic Shock

Keywords

septic shocknorepinephrinevasopressinhypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension

    Hypotension is defined as mean arterial pressure is less than 65mmHg

    One hour after dose reduction of vasopressors

Secondary Outcomes (5)

  • Time of hypotension

    One hour after dose reduction of vasopressors

  • Vasopressor free day

    28 days after dose reduction of vasopressors

  • 28-day mortality

    28 days

  • ICU mortality

    3 months

  • In-hospital mortality

    3 months

Study Arms (2)

Vasopressin

ACTIVE COMPARATOR

Vasopressin will be reduced first (0.01 U/hour)

Drug: Vasopressin

Norepinephrine

ACTIVE COMPARATOR

Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Drug: Norepinephrine

Interventions

VasopressinDRUG

Vasopressin will be reduced first (0.01 U/hour)

Vasopressin
NorepinephrineDRUG

Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Norepinephrine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29784057DERIVED

MeSH Terms

Conditions

Shock, SepticDiabetes InsipidusHypotension

Interventions

VasopressinsNorepinephrine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • kyeongman Jeon, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 15, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

KR(1)