Daily use of a muscle pump activator device reduces duration of hospitalization and improves early graft outcomes post-kidney transplantation: A randomized controlled trial.
Xie, W., et al.Canadian Urological Association Journal 2020 [record in progress].
Aims
This study aimed to investigate the effects of thrombo-embolic-deterrent (TED) stockings plus intermittent pneumatic compression (IPC) devices compared to muscle pump activator (MPA) devices on factors that could reduce complications related to kidney and simultaneous pancreas-kidney (SPK) transplantation and duration of hospitalization.
Interventions
Patients were randomized to either the intervention (MPA) group or the control (TED+IPC) group
Participants
221 patients undergoing renal and SPK transplantation.
Outcomes
The primary outcomes were lower-limb edema and total urine output between post-operative day (POD) 1 to 6. The secondary outcomes were the incidence of delayed graft function (DGF), duration of stay, number of dialysis sessions posttransplant, mobility and renal blood flow.
Follow-up
Up to 30 days
CET Conclusions
This is an interesting open-label RCT of a new device, the geko Muscle Pump Activator (MPA), which is a watch-sized strap worn around the upper calf. It stimulates the common peroneal nerve once per second, causing a muscular contraction in the calf and forcing venous return. The study was industry-funded by the producers of the geko device. Participants were randomized by an online computer system to receive geko therapy or to have standard anti-embolic stockings (TEDS) + Intermittent Pneumatic Compression (IPC). Devices were removed on the day of discharge. The study was powered for a difference in calf diameter between day 1 and 6 post op, and also the difference in total urine output in the first 6 days. Two patients could not tolerate the MPA, and another had no muscle stimulation with it, so were crossed over to the control arm and were assessed as such, which is not best practice. However, this was a small percentage of the study group (110 patients). The results showed a significantly smaller increase in calf size, and significantly smaller increase in total body weight with the MPA compared to TEDS+IPC. The MPA group also had a significantly increased 6-day total urine output (15.99+/-8.8L versus 12.6+/-8.4L). There was no significant difference in serum creatinine on day 6 or rate of DGF. There were similarly low rates of DVT in both groups. What is not clear, but is very important, is for how long each day patients in the two groups would wear their devices for. If patients had to remain in bed to wear the IPC devices then there is a significant confounding factor here, as they may be inclined to wear them for less of the day, or to be generally less mobile. Patients in the MPA group clocked up a significantly increased number of steps each day and this may actually be the reason for the improved fluid status; the venous return achieved by this MPA has previously been estimated to be approximately 60% of that produced by walking.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT01860820