Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000087550
Ethics application status
Approved
Date submitted
25/02/2006
Date registered
1/03/2006
Date last updated
1/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The haemodynamic effects of Vasopressin in early hyperdynamic septic shock
Scientific title
The haemodynamic effects of Vasopressin in early hyperdynamic septic shock
Universal Trial Number (UTN)
Trial acronym
VANNISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic Schock 1051 0
Condition category
Condition code
Blood 1131 1131 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who meet the inclusion criteria will receive a continous intravenous infusion of Vasopressin to maintain MAP > 70mmHg up to 72 hours.
Intervention code [1] 919 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1516 0
1. Resolution of shock
Timepoint [1] 1516 0
At 72 hours and 7 days
Primary outcome [2] 1517 0
2. Resolution of organ dysfunction:
i) SOFA score
ii) Specific markers of organ dysfunction
Timepoint [2] 1517 0
SOFA score at 72hrs and 7 days.
Specific markers of organ dysfunction at 24hrs, 72hrs and 7 days.
Secondary outcome [1] 2738 0
1. Length of mechanical ventilation in ICU
Timepoint [1] 2738 0
Secondary outcome [2] 2739 0
2. ICU Length of stay
Timepoint [2] 2739 0
Secondary outcome [3] 2740 0
3. Hospital length of stay
Timepoint [3] 2740 0

Eligibility
Key inclusion criteria
1. Informed consent obtained 2. PiCCO and/or a pulmonary artery catheter in situ. 3. Severe sepsis and septic shock diagnosed less than 24 hours prior to enrollment. 4. Severe sepsis will be defined as the presence of clinical and laboratory evidence suggestive of infection induced systemic inflammatory response to a possible infection with acute organ dysfunction. Septic shock will be defined as severe sepsis associated with a MAP < 70 mm Hg for a minimum of 30 minutes (or a fall in systolic blood pressure (SBP) > 40 mm Hg for patients with pre-existing hypertension) despite optimal fluid resuscitation or the requirement for vasoconstrictor support for at least 2 hours to maintain a MAP >70 mm Hg where vasoconstrictor support is defined as noradrenaline > 0.05 ug/kg/min, adrenaline > 0.05 ug/kg/min or dopamine > 3 ug/kg/min Optimal fluid resuscitation will be defined as either a global end-diastolic volume index >750 mL/m2 and an intra-thoracic blood volume > 900 mL/m2 as measured by PiCCO or a pulmonary artery occlusion pressure (PAOP) of 15 to 18 mmHg and /or a sustained (> 30 minutes) rise in PAOP of > 3 mm Hg after a 5 mLkg-1 blood product or colloid fluid challenge over 20 minutes. 5. CI > 3.5 L/min/m2 6. A dedicated central venous line lumen for infusion of study drug.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females of child bearing age – no pregnancy test available2. Age < 18 years3. Vasoconstrictor support for less than 2 hours duration (vasoconstrictor support as defined in inclusion criteria) 4. Shock refractory to noradrenaline, defined as a MAP of < 70 mm Hg associated with a noradrenaline infusion rate of > 1.0 ug/kg/min.5. Moribund pts unlikely to survive6. Previously documented significant non-revascularised coronary artery disease i.e. any coronary arterial occlusion of greater than 70%.7. New York Heart Association classification III or IV or pre-morbid LVEF of less than 30%.8. Recent MI < 3 months prior to enrolment or recent functional class II Angina.9. Acute ECG or biochemical evidence of myocardial ischaemia. 10. C.I. of less than 3.5 l/min/m2 as measured by PiCCO or pulmonary artery catheter. 11. Previously documented cirrhosis and/or severe liver dysfunction (INR >2, bilirubin >50) or clinical evidence of portal hypertension.12. The presence of ischaemic gut (documented or high suspicion) or abdominal angina.13. Chronic renal failure requiring dialysis (i.e. haemo- or peritoneal).14. Irreversible medical condition with imminent death (< 24 hours) or lack of commitment to full support (mechanical ventilation, haemodialysis etc) 15. Chemotherapy in last 30 days.16. Significant steroid use of >1mg/kg for 3 days or more in the last 7 days prior to admission to ICU.17. Consent refused or revoked.18. Allergy to iodine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1233 0
Charities/Societies/Foundations
Name [1] 1233 0
Intensive care research fund
Country [1] 1233 0
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 1090 0
None
Name [1] 1090 0
Nil
Address [1] 1090 0
Country [1] 1090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2561 0
Prince of Wales ehtics
Ethics committee address [1] 2561 0
Ethics committee country [1] 2561 0
Australia
Date submitted for ethics approval [1] 2561 0
Approval date [1] 2561 0
09/04/2003
Ethics approval number [1] 2561 0
Ethics committee name [2] 2562 0
Wentworth area health service
Ethics committee address [2] 2562 0
Ethics committee country [2] 2562 0
Australia
Date submitted for ethics approval [2] 2562 0
Approval date [2] 2562 0
23/02/2003
Ethics approval number [2] 2562 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36033 0
Address 36033 0
Country 36033 0
Phone 36033 0
Fax 36033 0
Email 36033 0
Contact person for public queries
Name 10108 0
Naomi Hammond
Address 10108 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10108 0
Australia
Phone 10108 0
+61 2 93824720
Fax 10108 0
+61 2 93824748
Email 10108 0
[email protected]
Contact person for scientific queries
Name 1036 0
Dr Yahya Shehabi
Address 1036 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1036 0
Australia
Phone 1036 0
+61 2 93824721
Fax 1036 0
+61 2 93824870
Email 1036 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.