NCT00197938

Brief Summary

Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of lactic acid. The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2005

Typical duration for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

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

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
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

First QC Date

September 14, 2005

Last Update Submit

June 5, 2009

Conditions

Septic Shock

Interventions

Measurement of rectal lactic acid.PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with early septic shock (\< 24 h).

You may qualify if:

  • Fluid resuscitated septic shock \< 24 h.

You may not qualify if:

  • Septic shock \> 24 h.
  • Pathology in the rectum.
  • Bleeding per rectum.
  • Limitation of therapy.
  • Where informed consent from relatives cannot be obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dept. of Intensive Care 4131, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Dept. of Intensive Care, Glostrup University Hospital

Glostrup Municipality, DK-2600, Denmark

Location

Dept. of Intensive Care, Gentofte University Hospital

Hellerup, DK-2900, Denmark

Location

Dept. of Intensive Care, Herlev University Hospital

Herlev, DK-2730, Denmark

Location

Dept. of Intensive Care, Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • Ibsen M, Tenhunen J, Wiis J, Waldau T, Lauritsen AO, Thornberg K, Joensen H, Perner A. Lactate concentrations in the rectal lumen in patients in early septic shock. Acta Anaesthesiol Scand. 2010 Aug;54(7):827-32. doi: 10.1111/j.1399-6576.2010.02263.x. Epub 2010 Jun 15.

    PMID: 20560883DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Anders Perner, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

November 1, 2005

Study Completion

April 1, 2009

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

DK(4)FI(1)