NCT00197886

Brief Summary

Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid. This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

September 14, 2005

Last Update Submit

September 19, 2006

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • L-lactate concentration in the rectum and stomach.

Interventions

Changing dose of norepinephrine and blood pressureDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock
  • NE-dose \> 0.1 microg/kg/min
  • CI \> 3.0 l/min/m2

You may not qualify if:

  • Age \< 18, unable to obtain informed consent from relatives
  • Untreated hypertension
  • Pregnancy
  • Pathology in the rectum or stomach
  • Limitation of therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care, Herlev University Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Anders Perner, MD,PhD

    Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Study Completion

December 1, 2005

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

DK(1)