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The safety and feasibility of Movement On renal replacement therapy via Vascath Evaluation in ICU patients: a pilot study

The safety and feasibility of Movement On renal replacement therapy via Vascath Evaluation in ICU patients: a pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000733976
Acronym
MOVE (Movement On renal replacement therapy via Vascath Evaluation)
Enrollment
40
Registered
2011-07-13
Start date
2011-10-25
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Monash Medical Centre Physiotherapy Department
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients admitted to ICU at MMC or Dandenong and commenced on continuous veno-venous haemodiafiltration (CVVHDF) via femoral vascath

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026