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The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

NCT ID: NCT00493415

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Sepsis Septic Shock

Keywords

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microcirculation sepsis nitroglycerine SDF imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

nitroglycerine iv

Group Type EXPERIMENTAL

nitroglycerin iv

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

placebo = nacl 0.9%

Intervention Type DRUG

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

Interventions

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nitroglycerin iv

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

Intervention Type DRUG

placebo = nacl 0.9%

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

Intervention Type DRUG

Other Intervention Names

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nitropohl isotonic saline

Eligibility Criteria

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Inclusion Criteria

* Severe sepsis
* Proven infection
* Informed consent

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Medical Center Leeuwarden

Principal Investigators

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E C Boerma, MD

Role: PRINCIPAL_INVESTIGATOR

Frisius Medisch Centrum

Locations

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Medical Centre Leeuwarden - Intensive Care Unit

Leeuwarden, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 19730258 (View on PubMed)

Other Identifiers

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ABR 12558

Identifier Type: -

Identifier Source: secondary_id

Eudract 2006-004298-88

Identifier Type: -

Identifier Source: secondary_id

CCMO NL12558.099.06

Identifier Type: -

Identifier Source: secondary_id

TPO 436

Identifier Type: -

Identifier Source: org_study_id