ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001194752

Ethics application status

Approved

Date submitted

28/10/2013

Date registered

30/10/2013

Date last updated

18/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin vs. Placebo in Cardiac Surgery Patients with the Post-operative High Cardiac Output and Hypotension syndrome

Scientific title

A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin vs. Placebo in Cardiac Surgery Patients with the Post-operative High Cardiac Output and Hypotension syndrome

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

STEP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-operative high cardiac output and hypotension syndrome in patients following cardiac surgery

Condition category

Condition code

Surgery

Other surgery

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravenous push of Terlipressin (Lucassin) 0.85mg, at baseline as a minimum and then 6 hourly for a maximum of 24 hours with the need for further doses determined by continuous invasive monitoring via an arterial line.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Normal Saline (0.9%)

Control group

Placebo

Outcomes

Primary outcome [1]

Mean arterial blood pressure via continuous invasive monitoring via arterial line

Timepoint [1]

one hour after each intravenous drug administration

Secondary outcome [1]

Cardiac output via invasive thermodilution monitoring

Timepoint [1]

one hour after each intravenous drug administration

Secondary outcome [2]

Central venous pressure via invasive central venous catheter

Timepoint [2]

one hour after each intravenous drug administration

Secondary outcome [3]

Pulmonary artery pressure via invasive pulmonary artery catheter

Timepoint [3]

one hour after each intravenous drug administration

Secondary outcome [4]

Intravenous fluid given as per fluid balance chart

Timepoint [4]

one hour after each intravenous drug administration

Secondary outcome [5]

Intravenous fluid given as per fluid balance chart

Timepoint [5]

In the first 6 hours after intravenous drug administration

Secondary outcome [6]

Intravenous fluid given as per fluid balance chart

Timepoint [6]

In the first 24 hours after intravenous drug administration

Secondary outcome [7]

Blood creatinine levels

Timepoint [7]

At baseline and in the first 3 days after randomisation

Secondary outcome [8]

Incidence of acute kidney injury based on creatinine according to risk, injury, failure, loss, end-stage (RIFLE) classification

Timepoint [8]

In the first three days after randomisation

Eligibility

Key inclusion criteria

- Patients aged 18 years or older
- Admitted to the intensive care unit after cardiopulmonary bypass
- High cardiac index (greater than 3 litres/minute/m2)
- Hypotension (systolic blood pressure less than 90 mmHg or mean arterial blood pressure less than 65 mmHg)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

- Pregnancty
- Death is considered imminent (within 24 hours)
- Known sever peripheral vascular disease
- Raynaud's phenomenon
- Known allergy to terlipressin
- Unstable angina
- Recent myocardial infarction
- Asthma
- Surgery for coronary artery disease

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligible patients will be randomised to receive either:
- Terlipressin at 0.85mg IV push, OR
- Placebo (Normal Saline 0.9%)

The study treatments will be macroscopically identical and will be supplied in identical 5 ml syringes prepared by ICU research staff.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be by means of sealed envelopes with permuted blocks of variable size.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Outcomes will be compared after log transformation where appropriate. Comparisons will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data. A Kaplan-Meier curve with log-rank test will be performed to further compare in-hospital mortality and rate of discharge home. Logistic regression analysis will also be performed to adjust for baseline imbalances. Analysis will be on intention-to-treat.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2018

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Banyule

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Anaesthesia Intensive Care Trust Fund, Austin Hospital, Austin Health

Address [1]

c/o Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/02/2014

Approval date [1]

17/06/2014

Ethics approval number [1]

Summary

Brief summary

The management of patients who have a high cardiac output (the amount of blood pumped by the heart every minute) and a low blood pressure after open heart surgery is complex because the best way to deliver best post-operative treatment of the circulation is uncertain. However, treatment typically includes the use of fluids given though a vein and drugs to help increase blood pressure to safer levels. Such blood pressure drugs can be useful but can have adverse effects on heart function or cause disturbances of the heart rhythm. Thus, they are often avoided and used very late in the management of these patients when blood pressure is really low. As a consequence, blood pressure may remain undesirably low for a long time and patients may be given large amounts of fluids instead, which can also be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients who have a high cardiac output with low blood pressure and worsening kidney function. 

Terlipressin can be given as a single shot through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with a high cardiac output and a low blood pressure after heart surgery without the risk of causing heart injury and rhythm disturbances. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in such selected cardiac surgery patients. 

In this study we wish to test whether, in open heart surgery patients with a high cardiac output but a low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment is safe and changes the amount of fluid given and kidney function for the better.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/365211-HREC14Austin217 Ethics Approval Site Authorisation SINGLE SITE.pdf

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 5992

Email

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+ 61 3 9496 3932

Email

rinaldo.bellomo@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

Email

rinaldo.bellomo@austin.org.au

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.