1) To determine if the 24 hour admission with TM can be omitted safely in the setting of CER for patients with low- and intermediate risk syncope (non-inferiority) 2) to determine the health care cost reduction (superiority), 3) additional…
ID
Source
Brief title
Condition
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>Primary: (non-)fatal serious adverse events in both arms (non-inferiority) </p>
Secondary outcome
<p>Secondary: healthcare costs and hospital utilization (superiority), proportion<br />
of additional diagnoses in both treatment arms after 24 hrs and 7 days of<br />
ambulant holter monitoring and QoL during 1 month after presentation on ED.</p>
Background summary
Syncope is very common and has a broad differential diagnosis. Guidelines on
syncope recommend to apply guideline based syncope algorithm (SA) to identify
low- / intermediate risk syncope patients and recommend to discharge these
patients (class 1, level of evidence B). Nevertheless, these patients are still
frequently admitted for 24 hour observation with telemetry (TM) on the Cardiac
Emergency Room (CER). There seems to be an equipoise for both treatment
strategy arms in current medical practice. A randomized controlled trial to
compare the 24 hour observation including TM with immediate discharge has never
been done on the CER.
Study objective
1) To determine if the 24 hour admission with TM can be omitted safely in the
setting of CER for patients with low- and intermediate risk syncope
(non-inferiority) 2) to determine the health care cost reduction (superiority),
3) additional diagnostic yield of both arms and 4) QoL after one moth follow up
(SFS 12 and SFSQ).
Study design
multicenter prospective randomized controlled comparison of immediate discharge
and admission for 24 hour observation with TM.
Study burden and risks
The study carries no risk. Both treatment strategy arms are already part of
clinical practice and applied randomly by physicians on the CER to patients
with low- / intermediate syncope. In this trial the guideline based SA will be
part of routine care to all patients with suspected syncope in order to
identify the eligible patients with low- / intermediate risk syncope.
Participation burden is limited to questionnaires. The questionnaires relate to
symptom burden, quality of life and health care costs/hospital utilization. We
do not believe that the questionnaires are offensive to the study participants.
Filling out these questionnaires does, however, cost time. Patients are able to
schedule this as they like. Study participation has no benefit for their
personal treatment. It has however the advantage that the study will help to
improve syncope care. We believe that the lack of risk, the limited study
burden and the possibility to terminate the study at any time, justifies the
study in this patient group.
T.T. Boel
Meibergdreef 9
Amsterdam 1102MX
Netherlands
0642819194
risctrial@amsterdamumc.nl
T.T. Boel
Meibergdreef 9
Amsterdam 1102MX
Netherlands
0642819194
risctrial@amsterdamumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
All patients with low risk- and intermediar risk syncope presented on the
Cardiac Emergency Care, will be eligible for the study.
Exclusion criteria
(1) Those aged <18 years
(2) Those in whom syncope / transient loss of consciousness co-exisits with
trauma or other serious condition identified in the CER (massive bleeding,
pulmonary embolus) or any high-risk features upon assessment with guideline
based SA (see appendix 2)
(3) Those with any other conditions then syncope / transient loss of
consciousness for which admission is required (including social indication for
admission, etc.)
(4) Contraindication for early discharge at the discretion of the responsible
physician
(5) Those with a learning disability
(6) Those presenting with pre-syncope
(7) Those who are unwilling to provide informed consent (those will be asked to
be enrolled for the SYNCOPE R.I.S.C - registry)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81736.018.22 |
| Research portal | NL-007311 |