HemofiltrationSIMHeRNCT02379234
Simulation for Continuous Veno-venous Hemofiltration in Intensive caRe
A study testing simulation in people with Hemofiltration and Nurse Training, run by University Hospital, Angers at 1 site in France.
Trial summary
Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy in intensive care units for patients with acute renal failure. In theory, this therapy should be continuous, 24 hours/day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemofiltration, Nurse Training, Health Care Provider Education
- What is being tested?
- simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ICU-nurses were recruited.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIMulation for HEmofiltration in Intensive caRe Unit
Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy in intensive care units for patients with acute renal failure. In theory, this therapy should be continuous, 24 hours/day.
However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled, with frequent "circuit down-times" (between 1 to 6 hours/day). There are many reasons for premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions, particularly in case of alarms.
Read more
High-fidelity simulation has been recently proposed for health care provider education. It has been consistently associated with large effects for outcomes of knowledge, skills, and behaviors but with moderate effects for patient related outcomes. Indeed, few studies have assess the impact of simulation on patient outcome following complexe procedures, that implies team work in addition to individual skills.
In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in addition to the dialysis that we already used). Before implementing this new technic in the ICU, investigators designed this study in order assess wether a high-fidelity based ICU-nurses education program would improve the outcome of CVVH sessions, compared to the conventional education program, proposed by the CVVH manufacturer.
Read the detailed description
All nurses of our 12-beds surgical ICU were randomized to one of the two arms for CVVH training (ie "conventional", the control arm, or "conventional + high-fidelity simulation", the intervention arm). Randomization was stratified according to nurse's experience with dialysis (i.e. defined as novice, standard or expert).
Then, all CVVH sessions performed in the ICU, were randomized to be supervised by nurses of one of the two arms only. The nurse in charge of the patient could thus be changed, depending on his/her group (note that the usual ratio is 1 nurse for 2.5 patients). Investigators use a minimization algorithm for this randomization, that take into account the presence of shock, counter-indication for heparin use, patient's agitation, site of dialysis catheter insertion (ie. Internal jugular or femoral) and previous early ending of the session. Prescription of CVVH was standardized (ie. Objective of 35 ml/kg/h of ultrafiltrate, with 1/3 in predilution and 2/3 post-dilution), and used unfractionated heparin.
All CVVH parameters (i.e. pressures, flow, alarms…) were recorded continuously, using a computer. In addition, hemodynamic parameters and biological parameters were prospectively recorded every 3 hours.
Prescription of CVVH ending should be timely written by the doctors. Nurses were asked to clearly record the time of CVVH session ending. An ending appearing less than 4 hours before the scheduled arrest of the session is considered as a "prematurely ending". Total and effective duration of each session were also recorded , as well as the total volume of ultrafiltrate.
- Being tested
- simulation
- Keywords
- CVVH, Renal replacement therapy, High fidelity simulation, Nurse training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationOther
Nurses received, in addition to the conventional formation (as in the control arm), a set of 3 high-fidelity simulation sessions. Each session lasted 1 to 2 hours, used high fidelity mannequin and CVVH generator and took place in an ICU room environment. For each session, a specific scenario was designed, the session began with a briefing and ended with a debriefing, based on video recording.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All nurses received a 4 hours formation, called "conventional formation", given by a professional trainer, that included 2 hours of theorical formation and 2 hours of practical training, based on CVVH generator demonstration. In addition, the trainer was present in the ICU during the first week of CVVH implementation, to answer any questions and to help nurses with their first CVVH sessions |
| Simulated | Experimental | The 'Simulated formation',used high fidelity mannequin and CVVH generator, is composed of 3 training sessions of 2 hours each one. This formation is associated with the 'conventional formation'. Receives: Other: simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of CVVH sessions ended prematurely as measured by a percentage
Measured: Two years
Secondary outcomes (3)
Management of CVVH generator alarms during the sessions as measured by the number of 'calling for help' during the session
Measured: 72 hours
efficacy of CVVH session measured by creatinine and bilirubin rate
Measured: 72 hours
Evaluation of nurses satisfaction measured by a quiz
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2014
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemofiltrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We performed a 2-phase (training and evaluation), randomized, single-center, open study: During the training phase, intensive care unit nurses underwent a 6-hour training pro- gram and were randomized to receive (intervention) or not (control) an additional high-fidelity simulation training (6 hours). During the evaluation phase, management of CRRT sessions was randomized to either intervention or control nurses.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond Lasocki, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379234
- Sponsor's protocol ID
- 49RC13_0209
- Acronym
- SIMHeR
- Status last verified
- Nov 2020
- First submitted
- 12 Feb 2015
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemarie P, Husser Vidal S, Gergaud S, Verger X, Rineau E, Berton J, Parot-Schinkel E, Hamel JF, Lasocki S. High-Fidelity Simulation Nurse Training Reduces Unplanned Interruption of Continuous Renal Replacement Therapy Sessions in Critically Ill Patients: The SimHeR Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):121-128. doi: 10.1213/ANE.0000000000003581.
PubMed 29933269
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMulation for HEmofiltration in Intensive caRe Unit
- ClinicalTrials.gov ID
- NCT02379234
- Acronym / sponsor ID
- SIMHeR / 49RC13_0209
- Keywords
- CVVH, Renal replacement therapy, High fidelity simulation, Nurse training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2014
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy in intensive care units for patients with acute renal failure. In theory, this therapy should be continuous, 24 hours/day.
However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled, with frequent "circuit down-times" (between 1 to 6 hours/day). There are many reasons for premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions, particularly in case of alarms.
High-fidelity simulation has been recently proposed for health care provider education. It has been consistently associated with large effects for outcomes of knowledge, skills, and behaviors but with moderate effects for patient related outcomes. Indeed, few studies have assess the impact of simulation on patient outcome following complexe procedures, that implies team work in addition to individual skills.
In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in addition to the dialysis that we already used). Before implementing this new technic in the ICU, investigators designed this study in order assess wether a high-fidelity based ICU-nurses education program would improve the outcome of CVVH sessions, compared to the conventional education program, proposed by the CVVH manufacturer.
Detailed description
All nurses of our 12-beds surgical ICU were randomized to one of the two arms for CVVH training (ie "conventional", the control arm, or "conventional + high-fidelity simulation", the intervention arm). Randomization was stratified according to nurse's experience with dialysis (i.e. defined as novice, standard or expert).
Then, all CVVH sessions performed in the ICU, were randomized to be supervised by nurses of one of the two arms only. The nurse in charge of the patient could thus be changed, depending on his/her group (note that the usual ratio is 1 nurse for 2.5 patients). Investigators use a minimization algorithm for this randomization, that take into account the presence of shock, counter-indication for heparin use, patient's agitation, site of dialysis catheter insertion (ie. Internal jugular or femoral) and previous early ending of the session. Prescription of CVVH was standardized (ie. Objective of 35 ml/kg/h of ultrafiltrate, with 1/3 in predilution and 2/3 post-dilution), and used unfractionated heparin.
All CVVH parameters (i.e. pressures, flow, alarms…) were recorded continuously, using a computer. In addition, hemodynamic parameters and biological parameters were prospectively recorded every 3 hours.
Prescription of CVVH ending should be timely written by the doctors. Nurses were asked to clearly record the time of CVVH session ending. An ending appearing less than 4 hours before the scheduled arrest of the session is considered as a "prematurely ending". Total and effective duration of each session were also recorded , as well as the total volume of ultrafiltrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We performed a 2-phase (training and evaluation), randomized, single-center, open study: During the training phase, intensive care unit nurses underwent a 6-hour training pro- gram and were randomized to receive (intervention) or not (control) an additional high-fidelity simulation training (6 hours). During the evaluation phase, management of CRRT sessions was randomized to either intervention or control nurses.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All nurses received a 4 hours formation, called "conventional formation", given by a professional trainer, that included 2 hours of theorical formation and 2 hours of practical training, based on CVVH generator demonstration. In addition, the trainer was present in the ICU during the first week of CVVH implementation, to answer any questions and to help nurses with their first CVVH sessions |
| Simulated | Experimental | Other: simulationThe 'Simulated formation',used high fidelity mannequin and CVVH generator, is composed of 3 training sessions of 2 hours each one. This formation is associated with the 'conventional formation'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All ICU-nurses were recruited.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulationNurses received, in addition to the conventional formation (as in the control arm), a set of 3 high-fidelity simulation sessions. Each session lasted 1 to 2 hours, used high fidelity mannequin and CVVH generator and took place in an ICU room environment. For each session, a specific scenario was designed, the session began with a briefing and ended with a debriefing, based on video recording. | Other | Simulated |
Primary outcome
percentage of CVVH sessions ended prematurely as measured by a percentage
Time frame: Two years
3 secondary outcomes
Management of CVVH generator alarms during the sessions as measured by the number of 'calling for help' during the session
Time frame: 72 hours
efficacy of CVVH session measured by creatinine and bilirubin rate
Time frame: 72 hours
Evaluation of nurses satisfaction measured by a quiz
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Results publication: PubMed 29933269Lemarie P, Husser Vidal S, Gergaud S, Verger X, Rineau E, Berton J, Parot-Schinkel E, Hamel JF, Lasocki S. High-Fidelity Simulation Nurse Training Reduces Unplanned Interruption of Continuous Renal Replacement Therapy Sessions in Critically Ill Patients: The SimHeR Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):121-128. doi: 10.1213/ANE.0000000000003581.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigismond Lasocki principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation in people with Hemofiltration and Nurse Training, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of CVVH sessions ended prematurely as measured by a percentage (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.