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CompletedNCT00493415NISMISUpdated Jul 16, 2008

The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

A Phase 3 interventional study of nitroglycerin iv and placebo = nacl 0.9% in Sepsis and Septic Shock, sponsored by Frisius Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-07-16.

Sponsored by Frisius Medisch Centrum · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.

Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).

Read the detailed description

This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters.

Informed consent is obtained of the relatives.

02

Conditions studied

  • Sepsis
  • Septic Shock

Keywords

  • microcirculation
  • sepsis
  • nitroglycerine
  • SDF imaging
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's enrollment of 70 is below the median of 105 across 918 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Frisius Medisch Centrum is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Severe sepsis
  • Proven infection
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
  • Pregnancy
  • Use of nitroglycerine within 24 hours prior to ICU admittance
  • Necessity to use nitroglycerine iv for instable angina
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    1

    nitroglycerine iv

    Drug: nitroglycerin iv

  • Placebo comparator
    2

    nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes

    Drug: placebo = nacl 0.9%

Interventions

  • Drugnitroglycerin iv

    loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes

    Also known as: nitropohl

  • Drugplacebo = nacl 0.9%

    4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes

    Also known as: isotonic saline

06

What researchers measure

Primary outcomes

  1. increase of MFI by nitro-glycerine

    Time frame: 2 years

Secondary outcomes

  1. decrease of length of stay decrease of SOFA decrease of morbidity/mortality

    Time frame: 2 years

07

Study locations

1 site
  • Medical Centre Leeuwarden - Intensive Care Unit
    Leeuwarden, 8901 BR, Netherlands
08

References and documents

Publications

  • Boerma EC, Koopmans M, Konijn A, Kaiferova K, Bakker AJ, van Roon EN, Buter H, Bruins N, Egbers PH, Gerritsen RT, Koetsier PM, Kingma WP, Kuiper MA, Ince C. Effects of nitroglycerin on sublingual microcirculatory blood flow in patients with severe sepsis/septic shock after a strict resuscitation protocol: a double-blind randomized placebo controlled trial. Crit Care Med. 2010 Jan;38(1):93-100. doi: 10.1097/CCM.0b013e3181b02fc1. PubMed 19730258 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of Jul 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2007
First posted
Jun 28, 2007
Start
Jun 2007
Primary completionActual
Jul 2008
CompletionActual
Jul 2008
Last update
Jul 16, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00493415
Lead sponsor
Frisius Medisch Centrum
First posted
Jun 28, 2007
Start date
Jun 2007
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Jul 16, 2008

Study contacts

E C Boerma, MD
principal investigator · Frisius Medisch Centrum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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