Shock, SepticPhase 2/3NCT00269685
Comparison of Vasopressin and Other Pressors in Septic Shock
A Phase 2/3 study testing vasopressin in people with Shock, Septic, run by Université de Sherbrooke.
Trial summary
The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor. Vasopressin seems to be an interesting alternative in the treatment of septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- vasopressin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legally major patient presenting a septic shock.
- The time window between beginning of symptoms and onset of treatment is established at 12 hours.
- The patient must be intubated and mechanically ventilated.
- Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine.
- Patient presenting a cardiac index of at least 3 L/min/m2
Who cannot join
- Shock other than septic
- cardiac hypokinesia
- a pre-existing organic renal failure that needs hemodyalisis
- oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication
About this study
Official title: Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock
The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.
Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.
- Conditions
- Shock, Septic
- Being tested
- vasopressin
- Keywords
- Septic shock, catecholamine, vasopressin, tonometria, lactate
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock
Secondary outcomes (4)
To compare these two categories of treatment on:
tonometric parameters
renal function
in term of tolerance: metabolic effects (increase in lactate and glycaemia), cardiac effects (tachycardia being defined as a heart rate increase of 15%), increase of cardiac enzymes (troponine, CK, CK-MB), and cutanuous vasoconstriction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Lesur, Ph d, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269685
- Sponsor's protocol ID
- 00-33-R2
- Status last verified
- Aug 2005
- First submitted
- 22 Dec 2005
- Last updated
- 29 May 2006
- Results posted
- No
Publications
American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
PubMed 1597042Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.
PubMed 9054839Luk J, Ajaelo I, Wong V, Wong J, Chang D, Chou L, Reid IA. Role of V1 receptors in the action of vasopressin on the baroreflex control of heart rate. Am J Physiol. 1993 Sep;265(3 Pt 2):R524-9. doi: 10.1152/ajpregu.1993.265.3.R524.
PubMed 8214142Malay MB, Ashton RC Jr, Landry DW, Townsend RN. Low-dose vasopressin in the treatment of vasodilatory septic shock. J Trauma. 1999 Oct;47(4):699-703; discussion 703-5. doi: 10.1097/00005373-199910000-00014.
PubMed 10528604Reid IA. Role of vasopressin deficiency in the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1108-10. doi: 10.1161/01.cir.95.5.1108. No abstract available.
PubMed 9054835Rozenfeld V, Cheng JW. The role of vasopressin in the treatment of vasodilation in shock states. Ann Pharmacother. 2000 Feb;34(2):250-4. doi: 10.1345/aph.19066.
PubMed 10676834
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock
- ClinicalTrials.gov ID
- NCT00269685
- Acronym / sponsor ID
- 00-33-R2
- Conditions
- Shock, Septic
- Keywords
- Septic shock, catecholamine, vasopressin, tonometria, lactate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2000
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.
Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Legally major patient presenting a septic shock.
- The time window between beginning of symptoms and onset of treatment is established at 12 hours.
- The patient must be intubated and mechanically ventilated.
- Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine.
- Patient presenting a cardiac index of at least 3 L/min/m2
Key exclusion criteria (4 listed)
- Shock other than septic
- cardiac hypokinesia
- a pre-existing organic renal failure that needs hemodyalisis
- oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vasopressin | Drug | – |
Primary outcome
To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock
4 secondary outcomes
To compare these two categories of treatment on:
tonometric parameters
renal function
in term of tolerance: metabolic effects (increase in lactate and glycaemia), cardiac effects (tachycardia being defined as a heart rate increase of 15%), increase of cardiac enzymes (troponine, CK, CK-MB), and cutanuous vasoconstriction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2006.
- Background: PubMed 1597042American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
- Background: PubMed 9054839Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.
- Background: PubMed 8214142Luk J, Ajaelo I, Wong V, Wong J, Chang D, Chou L, Reid IA. Role of V1 receptors in the action of vasopressin on the baroreflex control of heart rate. Am J Physiol. 1993 Sep;265(3 Pt 2):R524-9. doi: 10.1152/ajpregu.1993.265.3.R524.
- Background: PubMed 10528604Malay MB, Ashton RC Jr, Landry DW, Townsend RN. Low-dose vasopressin in the treatment of vasodilatory septic shock. J Trauma. 1999 Oct;47(4):699-703; discussion 703-5. doi: 10.1097/00005373-199910000-00014.
- Background: PubMed 9054835Reid IA. Role of vasopressin deficiency in the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1108-10. doi: 10.1161/01.cir.95.5.1108. No abstract available.
- Background: PubMed 10676834Rozenfeld V, Cheng JW. The role of vasopressin in the treatment of vasodilation in shock states. Ann Pharmacother. 2000 Feb;34(2):250-4. doi: 10.1345/aph.19066.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Lesur, Ph d principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vasopressin in people with Shock, Septic, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269685, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2006.