The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
NISMIS
The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU
4 other identifiers
interventional
70
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 sepsis
Started Jun 2007
Shorter than P25 for phase_3 sepsis
1 active site
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
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJuly 16, 2008
July 1, 2008
1.1 years
June 27, 2007
July 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
increase of MFI by nitro-glycerine
2 years
Secondary Outcomes (1)
decrease of length of stay decrease of SOFA decrease of morbidity/mortality
2 years
Study Arms (2)
1
EXPERIMENTALnitroglycerine iv
2
PLACEBO COMPARATORnacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes
Interventions
loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes
4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
Eligibility Criteria
You may qualify if:
- Severe sepsis
- Proven infection
- Informed consent
You may not qualify if:
- Age \< 18 years
- Pregnancy
- Use of nitroglycerine within 24 hours prior to ICU admittance
- Necessity to use nitroglycerine iv for instable angina
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Centre Leeuwarden - Intensive Care Unit
Leeuwarden, 8901 BR, Netherlands
Related Publications (1)
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.
PMID: 19730258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E C Boerma, MD
Frisius Medisch Centrum
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
July 16, 2008
Record last verified: 2008-07