Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000733976
Ethics application status
Approved
Date submitted
17/06/2011
Date registered
13/07/2011
Date last updated
4/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and feasibility of Movement On renal replacement therapy via Vascath Evaluation in ICU patients: a pilot study
Scientific title
The safety and feasibility of Movement On renal replacement therapy via Vascath Evaluation in ICU patients: a pilot study
Secondary ID [1] 262179 0
Nil
Universal Trial Number (UTN)
Trial acronym
MOVE (Movement On renal replacement therapy via Vascath Evaluation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 265859 0
Acute renal failure 265862 0
Condition category
Condition code
Physical Medicine / Rehabilitation 266016 266016 0 0
Physiotherapy
Renal and Urogenital 266019 266019 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The three interventions, respectively, will be as follows (n = 10 each group):

1.Non-responsive patients (not able to participate)
Five positions, 4 minutes each position.
i.Supine
ii.Hip flexion to 45 degrees, sustained
iii.Supine
iv.Hip flexion to 45 degrees, repeated movements
v.Supine

2.Low-level participants (unable to stand but participating)
Five positions, 4 minutes each position
i.Supine
ii.Hip flexion to 45 degrees, repeated movements
iii.Supine
iv.SOEOB (Sit On Edge Of the Bed) (if able)
v.Supine

3.High-level participants (able to stand with assistance)
Five positions, 4 minutes each position
i.Supine
ii.Standing
iii.MOS (Marching On the Spot)
iv.SOEOB (Sit On Edge Of the Bed)
v.Supine

4. An additional group of 10 participants who have internal jugular or sub-clavian vascaths will also be included (five low-level participants will undergo the low-level intervention and five high-level participants will undergo the high-level intervention).

The intervention duration will be 20 minutes each session.

The intervention will be delivered to each participant individually by trained physiotherapist(s).

Each participant will undergo the intervention session once as a part of the study.
Intervention code [1] 264584 0
Rehabilitation
Comparator / control treatment
Baseline data from routine care will be recorded for 20 patients across the two sites on the same primary outcomes of the intervention group.

Comparisons will be made within subjects as well as against baseline data.
Control group
Active

Outcomes
Primary outcome [1] 266762 0
Adverse events
(Bleeding, haematoma, bruising, thrombotic complications, catheter dislodgement, other)
Timepoint [1] 266762 0
Ongoing monitoring for adverse events from time of intervention up to 3 filters later
Primary outcome [2] 266869 0
Filter life
Filter life time will be measured in hours of duration of continuous renal replacement therapy, filter life time end when system clots or is removed. Reason for cessation of filtration will be recorded (e.g. elective removal vs. clotting of circuit).
Timepoint [2] 266869 0
At time of intervention
Secondary outcome [1] 276332 0
CVVHDF (continuous venovenous hemodiafiltration) parameters
Pre-intervention parameters will be copied from nursing observational chart
During intervention, parameters will be read from the machine and recorded minutely
Post-intervention parameters will be copied from nursing observational chart
Timepoint [1] 276332 0
Hourly for 24 hours before intervention
Minutely during intervention
Hourly for next 3 filters
Secondary outcome [2] 276334 0
CVVHDF alarm rates
Timepoint [2] 276334 0
at time of intervention
Secondary outcome [3] 276335 0
Subsequent filter life
Timepoint [3] 276335 0
for 3 filters after intervention
Secondary outcome [4] 276336 0
Nursing workload measured by survey given to nursing staff at baseline, during interventional shift and during shift following interventional shift.
Timepoint [4] 276336 0
At baseline, during interventional shift and during shift following interventional shift
Secondary outcome [5] 276337 0
Patient satisfaction measured by surveys (inc Likert scales) given to patients at baseline, post intervention and upon discharge from ICU
Timepoint [5] 276337 0
At baseline, after intervention and upon discharge from ICU

Eligibility
Key inclusion criteria
Patients admitted to ICU at MMC or Dandenong and commenced on continuous veno-venous haemodiafiltration (CVVHDF) via femoral vascath
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All eligible patients will be considered eligible to participate in a hip movement session unless they have any of the following clinical signs:
*Extreme agitation or confusion (Richmond Agitation Sedation Scale 3 or 4)
*Heart rate > 160 < 40 bpm or new arrhythmia developed (e.g. new onset atrial fibrillation)
*Limb movement restricted by reasons other than the presence of a vascath.

Patients will not be considered eligible to participate in a mobilization session (which includes sitting up at a minimum) if at the time of the planned session they have any of the following clinical signs:
*Extreme agitation or confusion (Richmond Sedation-Agitation Scale 3 or 4)
*Heart rate > 160 < 40 bpm or new arrhythmia developed (e.g. new onset atrial fibrillation)
*Mean arterial blood pressure (MABP) < 60 mm Hg > 120 mm Hg
*Patient requiring > 10 mcg/min noradrenaline (or equivalent vasopressor/ionotrope)
*FiO2 > 0.6, with PaO2 < 65 mm Hg
*Patient suffers a drop in SpO2 greater than 10% from resting level or SpO2 < 85%
*Patient respiratory rate > 35
*Patient temperature > 38.5 degrees
*A stand will not be attempted in patients who are drowsy or unable to follow commands
*Patient suffers new onset chest pain with suspected cardiac cause

Cessation criteria
Any session that is being carried out will be ceased if during the session, the patient meets any of the exclusion criteria not responsive to 2 minutes rest.

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)
*Patients are screened by Senior ICU Physio daily on weekdays
*Principal investigator(s) notified
*Investigator(s) screens patient for inclusion into study and allocate patient into one of three treatment groups:

Passive movements group: Patients not able to participate in physiotherapy treatment (e.g. due to sedation, low Glasgow Coma Score or severe weakness/debility, medical condition precluding mobilization (e.g. sitting up) as described in the Exclusion Criteria)

Sitting mobilisation group: patients with low-level physical function (defined as a likely inability to stand as assessed by the treating physiotherapist)

Standing mobilisation group: patients with high-level physical function (measured by a likely ability to stand as assessed by the treating physiotherapist)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will not be randomised as this is a pilot study that aims to assess the safety of the intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This will be a prospective study
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2011
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)
Recruitment postcode(s) [1] 4230 0
3168
Recruitment postcode(s) [2] 4098 0
3175

Funding & Sponsors
Funding source category [1] 267212 0
Hospital
Name [1] 267212 0
Monash Medical Centre Physiotherapy Department
Country [1] 267212 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre Physiotherapy Department
Address
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 266280 0
None
Name [1] 266280 0
Address [1] 266280 0
Country [1] 266280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269204 0
Southern Health HREC B
Ethics committee address [1] 269204 0
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 269204 0
Australia
Date submitted for ethics approval [1] 269204 0
30/05/2011
Approval date [1] 269204 0
Ethics approval number [1] 269204 0
11173B

Summary
Brief summary
Some patients are admitted to the intensive care unit (ICU) either with renal failure or develop renal failure during their stay. Renal failure in ICU is often treated with continuous renal replacement therapy, usually continuous veno-venous haemofiltration (CVVH) or continuous veno-venous haemodiafiltration (CVVHDF). The nature of continuous renal replacement therapy is that it is run over consecutive 24 hour periods (as long as the circuit remains patent). However, there is wide variability in the mobility restrictions imposed on patients undergoing CVVH or CVVHDF therapy in ICUs and patients may often remain immobilised and bed-bound whilst on renal replacement therapy. These mobility restrictions may contribute to the adverse effects of immobilisation in ICUs and there is some evidence to suggest that immobilisation secondary to a vascular catheter (vascath) increases risk of blood clots. Although there is no empirical evidence to suggest that mobilisation of patients with a vascath is detrimental, vascath manufacturers provide no guidance around the specifications of vascaths with movement. In some settings, patients undergoing CVVHDF or CVVH do mobilise out of bed and there is no evidence with which to guide practice around this. Empirical data is required to demonstrate the effects of patient movement on renal replacement therapy flows via vascath and treatment cessation in ICU. However, prior to determining the effect of movement on CVVHDF flows, the safety and feasibility of moving patients on renal replacement therapy must be established.
This pilot study will look at patients who have been admitted to an ICU and are requiring continuous renal replacement therapy via a vascath. The aim is to see if it is safe to move and mobilise patients who are having continuous renal replacement therapy via the vascath. Possible adverse events may involve the vascath being pulled out, clotting at the catheter site or in the blood vessels, bleeding or bruising at the catheter site. The settings and parameters on the dialysis machine will be measured to establish a baseline standard of renal replacement therapy flows and performance for comparison in future studies. The collected data will be analysed for safety and assessed for the feasibility of moving the hip or mobilising patients on CVVH or CVVHDF. The project will be written up for publication in an Australian Journal. Depending on the result of this pilot study, a study powered to examine the effects of mobilisation on haemofiltration circuit life may follow.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32611 0
Address 32611 0
Country 32611 0
Phone 32611 0
Fax 32611 0
Email 32611 0
Contact person for public queries
Name 15858 0
Michael (Yi Tian) Wang
Address 15858 0
Michael (Yi Tian) Wang
246 Clayton Road
Clayton
VIC 3168
Australia
Country 15858 0
Australia
Phone 15858 0
+61 3 9594 6666 pager 348
Fax 15858 0
Email 15858 0
michael.wang@southernhealth.org.au
Contact person for scientific queries
Name 6786 0
Elizabeth Skinner
Address 6786 0
Elizabeth Skinner
246 Clayton Road
Clayton
VIC 3168
Australia
Country 6786 0
Australia
Phone 6786 0
+61 3 9594 6666 pager 233
Fax 6786 0
Email 6786 0
elizabeth.skinner@southernhealth.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

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