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

Not Applicable

Completed

• Conditions: Critical illness; Acute renal failure; Physical Medicine / Rehabilitation - Physiotherapy; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12611000733976
• Lead Sponsor: Monash Medical Centre Physiotherapy Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events<br>(Bleeding, haematoma, bruising, thrombotic complications, catheter dislodgement, other)[Ongoing monitoring for adverse events from time of intervention up to 3 filters later];Filter life<br>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).[At time of intervention]

Secondary Outcome Measures

Name	Time	Method
CVVHDF (continuous venovenous hemodiafiltration) parameters<br>Pre-intervention parameters will be copied from nursing observational chart<br>During intervention, parameters will be read from the machine and recorded minutely<br>Post-intervention parameters will be copied from nursing observational chart[Hourly for 24 hours before intervention<br>Minutely during intervention<br>Hourly for next 3 filters];CVVHDF alarm rates[at time of intervention];Subsequent filter life[for 3 filters after intervention];Nursing workload measured by survey given to nursing staff at baseline, during interventional shift and during shift following interventional shift.[At baseline, during interventional shift and during shift following interventional shift];Patient satisfaction measured by surveys (inc Likert scales) given to patients at baseline, post intervention and upon discharge from ICU[At baseline, after intervention and upon discharge from ICU]