RhabdomyolysisNCT06338423
Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure
A study testing vacuum mattress and Standard Mattress in people with Rhabdomyolysis and Acute Kidney Injury, run by Jagiellonian University at 1 site in Poland.
Trial summary
This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhabdomyolysis, Acute Kidney Injury, Bariatric Surgery Candidate
- What is being tested?
- vacuum mattress and Standard Mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,184 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2015to 31 Dec 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 which will be qualified for LSG due to obesity
Who cannot join
- Patients with preoperative chronic renal failure will be excluded from the study. Other exclusion criteria are perioperative complications which require postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERAbSERABS ) Protocol < 85%.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Mecical Collage
Krakow, Lesser Poland Voivodeship, 31-501
About this study
This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.
Method Patients
Read more
A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:
- January 2015 - December 2016 - only standard mattresses were used
- January 2017 - December 2019 - both types of mattresses were used
- January 2020 - December 2022 - only vacuum mattresses were used
Participants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol < 85%.
Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center[]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.
End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.
Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day
- Being tested
- vacuum mattress, Standard Mattress
- Medical subject headings
- Rhabdomyolysis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum mattressDevice
vacuum mattresses used to better positioning of the patient
Standard MattressOther
Standard Mattress
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Mattress Arm | Experimental | Patients will be operated in a beach chair position. The patient will ley on vacuum mattresses during the surgery.
Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery. Receives: Device: vacuum mattress |
| Standard Mattress arm | Other | Patients will be operated in a beach chair position. The patient will ley on standard mattresses during the surgery.
Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery. Receives: Other: Standard Mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI)
The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which requireds additional treatment.
Measured: 30 day
Secondary outcomes (3)
Concentration of myoglobin marker
Measured: 1 day
Concentration of creatine kinase marker
Measured: 1 day
Concentration of creatinine marker
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jan 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Wierdak, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338423
- Sponsor's protocol ID
- JagiellonianU-08
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure
- ClinicalTrials.gov ID
- NCT06338423
- Acronym / sponsor ID
- JagiellonianU-08
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Mar 2024 (actual)
- 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.
This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.
Method Patients
A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:
- January 2015 - December 2016 - only standard mattresses were used
- January 2017 - December 2019 - both types of mattresses were used
- January 2020 - December 2022 - only vacuum mattresses were used
Participants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol < 85%.
Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center[]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.
End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.
Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum Mattress Arm | Experimental | Device: vacuum mattressPatients will be operated in a beach chair position. The patient will ley on vacuum mattresses during the surgery. Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery. |
| Standard Mattress arm | Other | Other: Standard MattressPatients will be operated in a beach chair position. The patient will ley on standard mattresses during the surgery. Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 which will be qualified for LSG due to obesity
Key exclusion criteria (1 listed)
- Patients with preoperative chronic renal failure will be excluded from the study. Other exclusion criteria are perioperative complications which require postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERAbSERABS ) Protocol < 85%.
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 |
|---|---|---|
| vacuum mattressvacuum mattresses used to better positioning of the patient | Device | Vacuum Mattress Arm |
| Standard MattressStandard Mattress | Other | Standard Mattress arm |
Primary outcome
Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI)
Time frame: 30 day
The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which requireds additional treatment.
3 secondary outcomes
Concentration of myoglobin marker
Time frame: 1 day
Concentration of creatine kinase marker
Time frame: 1 day
Concentration of creatinine marker
Time frame: 1 day
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 29 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vacuum mattress and Standard Mattress in people with Rhabdomyolysis and Acute Kidney Injury, run by Jagiellonian University at 1 site in Poland.
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 29 Mar 2024. 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 Poland. 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?
Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI) (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.