RhabdomyolysisNCT02671604
Rhabdomyolysis and Robot-assisted Radical Prostatectomy
An observational study of Rhabdomyolysis, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jan 2015
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients scheduled for an elective Robot assisted radical prostatectomy were enrolled to the study.
Who may be able to join
- ASA I-II
- Aged 50-80 years,
- BMI >25 kg/m2
- Patients scheduled for an elective RARP
Who cannot join
- Patients with ASA III-IV risk status,
- Patients with comorbid diseases that can cause increased muscular activity such as severe dystonia or status asthmaticus,
- Patients with renal or hepatic failure and patients on statin or steroid therapy were excluded.
- Patients converted to laparotomy during surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.
In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.
Read the detailed description
Fifty-two ASA I-II patients aged 50-80 years, BMI >25 kg/m2 scheduled for an elective RARP were enrolled to the study.
In all patients, pre-anesthetic evaluations including laboratory tests and Charlson Comorbidity Index (CCI) were performed one week before surgery in anesthesia clinic. Comorbid diseases were rated based on CCI. A 4-points scale was used to rate comorbid conditions [1 mild; 4 severe]. Comorbidity grading was performed by adding scores given for each comorbid disease. Based on the grading, patients were stratified into 4 groups as follows: grade 0, 1-2, 3-4 and ≥ 5
In the operation room, intubation was performed after standard anesthesia For surgery, patients were placed in low lithotomy position. All patients were placed on a soft sponge mattress and soft padding gel pads were provided above the shoulders. The patients were placed in a 30-degree STP after achieving pneumoperitoneum at an intra-abdominal pressure level of 15 mmHg. After placing patient to desired position (T0), blood samples were drawn for measurements of ABG, Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB and CPK.
During the operation, normal saline (1 m/kg/hr) and 6% HES 200/05 (1 ml/kg/hr) infusions were applied. Operation time (OT) and Trendelenburg time (TT) were recorded in all patients.
Blood samples were repeated on the hours 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery. Hydration with 2000 ml crystalloid solution was given until hour 24 after surgery. In all patients, urine output was monitored.
Rhabdomyolysis was defined as postoperative serum CPK level exceeding 5,000 IU/L. It was planned to manage these patients with hypervolemic therapy, correction of acidosis by using IV sodium bicarbonate and stimulation of diuresis by IV furosemide with a goal of maintaining minimal diuresis of 60 ml/hr at pH level of 7.
Postoperative RF was defined as an increase in serum creatinine of 1mg/dl/day (or 90 mmol/l/day) for 2 consecutive days beyond the baseline.
Patients were discharged with control laboratory tests, including the same parameters, on the hour 48 (T48) postoperatively.
- Conditions
- Rhabdomyolysis
- Keywords
- acute renal failure, prostatectomy, minimal invasive surgery
- Medical subject headings
- Rhabdomyolysis, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L
Rhabdomyolysis was defined as postoperative serum Creatine Phosphokinase level exceeding 5000 IU/L.
Measured: Change from Baseline Creatine Phosphokinase at 24 hours.
Secondary outcomes (1)
number of patients with abnormal laboratory values
Laboratory values of serum Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB
Measured: on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- eyup v kucuk, md, Study director, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671604
- Sponsor's protocol ID
- GK9
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim TK, Yoon JR, Lee MH. Rhabdomyolysis after laparoscopic radical nephrectomy -A case report-. Korean J Anesthesiol. 2010 Dec;59 Suppl(Suppl):S41-4. doi: 10.4097/kjae.2010.59.S.S41. Epub 2010 Dec 31.
PubMed 21286457Vijay MK, Vijay P, Kundu AK. Rhabdomyolysis and myogloginuric acute renal failure in the lithotomy/exaggerated lithotomy position of urogenital surgeries. Urol Ann. 2011 Sep;3(3):147-50. doi: 10.4103/0974-7796.84965.
PubMed 21976928
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
- ClinicalTrials.gov ID
- NCT02671604
- Acronym / sponsor ID
- GK9
- Conditions
- Rhabdomyolysis
- Keywords
- acute renal failure, prostatectomy, minimal invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Feb 2016 (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.
In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.
In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.
Detailed description
Fifty-two ASA I-II patients aged 50-80 years, BMI >25 kg/m2 scheduled for an elective RARP were enrolled to the study.
In all patients, pre-anesthetic evaluations including laboratory tests and Charlson Comorbidity Index (CCI) were performed one week before surgery in anesthesia clinic. Comorbid diseases were rated based on CCI. A 4-points scale was used to rate comorbid conditions [1 mild; 4 severe]. Comorbidity grading was performed by adding scores given for each comorbid disease. Based on the grading, patients were stratified into 4 groups as follows: grade 0, 1-2, 3-4 and ≥ 5
In the operation room, intubation was performed after standard anesthesia For surgery, patients were placed in low lithotomy position. All patients were placed on a soft sponge mattress and soft padding gel pads were provided above the shoulders. The patients were placed in a 30-degree STP after achieving pneumoperitoneum at an intra-abdominal pressure level of 15 mmHg. After placing patient to desired position (T0), blood samples were drawn for measurements of ABG, Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB and CPK.
During the operation, normal saline (1 m/kg/hr) and 6% HES 200/05 (1 ml/kg/hr) infusions were applied. Operation time (OT) and Trendelenburg time (TT) were recorded in all patients.
Blood samples were repeated on the hours 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery. Hydration with 2000 ml crystalloid solution was given until hour 24 after surgery. In all patients, urine output was monitored.
Rhabdomyolysis was defined as postoperative serum CPK level exceeding 5,000 IU/L. It was planned to manage these patients with hypervolemic therapy, correction of acidosis by using IV sodium bicarbonate and stimulation of diuresis by IV furosemide with a goal of maintaining minimal diuresis of 60 ml/hr at pH level of 7.
Postoperative RF was defined as an increase in serum creatinine of 1mg/dl/day (or 90 mmol/l/day) for 2 consecutive days beyond the baseline.
Patients were discharged with control laboratory tests, including the same parameters, on the hour 48 (T48) postoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for an elective Robot assisted radical prostatectomy were enrolled to the study.
Key inclusion criteria (4 listed)
- ASA I-II
- Aged 50-80 years,
- BMI >25 kg/m2
- Patients scheduled for an elective RARP
Key exclusion criteria (4 listed)
- Patients with ASA III-IV risk status,
- Patients with comorbid diseases that can cause increased muscular activity such as severe dystonia or status asthmaticus,
- Patients with renal or hepatic failure and patients on statin or steroid therapy were excluded.
- Patients converted to laparotomy during surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L
Time frame: Change from Baseline Creatine Phosphokinase at 24 hours.
Rhabdomyolysis was defined as postoperative serum Creatine Phosphokinase level exceeding 5000 IU/L.
1 secondary outcome
number of patients with abnormal laboratory values
Time frame: on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.
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 2 Feb 2016.
- Background: PubMed 21286457Kim TK, Yoon JR, Lee MH. Rhabdomyolysis after laparoscopic radical nephrectomy -A case report-. Korean J Anesthesiol. 2010 Dec;59 Suppl(Suppl):S41-4. doi: 10.4097/kjae.2010.59.S.S41. Epub 2010 Dec 31.
- Results publication: PubMed 21976928Vijay MK, Vijay P, Kundu AK. Rhabdomyolysis and myogloginuric acute renal failure in the lithotomy/exaggerated lithotomy position of urogenital surgeries. Urol Ann. 2011 Sep;3(3):147-50. doi: 10.4103/0974-7796.84965.
- Individual participant dataSharing planned: No
Related trials for Rhabdomyolysis
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Impact of Extrarenal Myoglobin Clearance on Renal Recovery in Patients With Severe Rhabdomyolysis
Rhabdomyolysis-Induced Renal Failure
Recruiting
Effect of Battlefield Acupuncture on Pain Control During Inpatient Treatment of Exertional Rhabdomyolysis
Rhabdomyolysis
Not yet recruiting
Evaluation of the Effectiveness of Using Virtual Reality Glasses in Prehospital Intervention Training for Crush Syndrome
Rhabdomyolysis, Virtual Reality
RecruitingPhase 1
Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
Rhabdomyolysis
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.
eyup v kucuk, md study director
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 2 Feb 2016. 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 Turkey (Türkiye). 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?
Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L (time frame: Change from Baseline Creatine Phosphokinase at 24 hours.). 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 NCT02671604, which also lists 2 linked publications.
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 2 Feb 2016.