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The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis (NISMIS)

Primary Purpose

Sepsis, Septic Shock

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
nitroglycerin iv
placebo = nacl 0.9%
Sponsored by
Medical Centre Leeuwarden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring microcirculation, sepsis, nitroglycerine, SDF imaging

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Centre Leeuwarden - Intensive Care Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

nitroglycerine iv

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

Outcomes

Primary Outcome Measures

increase of MFI by nitro-glycerine

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2007
Last Updated
July 15, 2008
Sponsor
Medical Centre Leeuwarden
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1. Study Identification

Unique Protocol Identification Number
NCT00493415
Brief Title
The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
Acronym
NISMIS
Official Title
The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Centre Leeuwarden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
microcirculation, sepsis, nitroglycerine, SDF imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
nitroglycerine iv
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
nitroglycerin iv
Other Intervention Name(s)
nitropohl
Intervention Description
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
Intervention Name(s)
placebo = nacl 0.9%
Other Intervention Name(s)
isotonic saline
Intervention Description
4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
Primary Outcome Measure Information:
Title
increase of MFI by nitro-glycerine
Time Frame
2 years
Secondary Outcome Measure Information:
Title
decrease of length of stay decrease of SOFA decrease of morbidity/mortality
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E C Boerma, MD
Organizational Affiliation
Medical Centre Leeuwarden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre Leeuwarden - Intensive Care Unit
City
Leeuwarden
ZIP/Postal Code
8901 BR
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19730258
Citation
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.
Results Reference
derived

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The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

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