Pulmonary EmbolismNCT04402749
The Incidence of Pulmonary Embolism During Nephrectomy
An observational study of Pulmonary Embolism and Renal Cell Carcinoma, run by Mahidol University at 1 site in Thailand.
Trial summary
Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Renal Cell Carcinoma, Nephrectomy
- What is being tested?
- Nephrectomy
- How many people
- 416 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2020to 30 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every adult patients with renal carcinoma underwent nephrectomy will be recruited.
Who may be able to join
- Adult patients with renal cancer undergoing nephrectomy
Who cannot join
- Patients with incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy
Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome.
Read the detailed description
Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava.
Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited.
The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome.
- Conditions
- Pulmonary Embolism, Renal Cell Carcinoma, Nephrectomy
- Being tested
- Nephrectomy
- Medical subject headings
- Pulmonary Embolism, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephrectomyOther
Patients underwent nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Nephrectomy | Patients underwent nephrectomy Receives: Other: Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy
Pulmonary embolism
- Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
- Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
Measured: intraoperative period
Secondary outcomes (5)
The incidence of postoperative PE of renal cancer patient undergoing nephrectomy
Pulmonary embolism
- Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
- Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
Measured: until 7 days after surgery
Length of stay
- Hospital stay
- ICU stay
Measured: 7 days after surgery
Number of patients with postoperative organ dysfunction
Organ dysfunction
- acute kidney injury
- acute respiratory distress syndrome
Measured: 7 days after surgery
Rate of TEE utilization
TEE utilization
- for monitoring (use when the case begins)
- for rescue (use when unexplained hypotension or hemodynamic collapsed)
Measured: 7 days after surgery
Mortality rate at 30 days postoperative
Patients death after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aphichat Suphathamwit, M.D., Principal investigator, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402749
- Sponsor's protocol ID
- 2020_2
- Status last verified
- Mar 2023
- First submitted
- 7 May 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011.
PubMed 21377083Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l.
PubMed 8212439Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026.
PubMed 17113889Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15.
PubMed 31072702
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy
- ClinicalTrials.gov ID
- NCT04402749
- Acronym / sponsor ID
- 2020_2
- Conditions
- Pulmonary Embolism, Renal Cell Carcinoma, Nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 May 2020 (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.
Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome.
Detailed description
Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava.
Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited.
The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nephrectomy | – | Other: NephrectomyPatients underwent nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every adult patients with renal carcinoma underwent nephrectomy will be recruited.
Key inclusion criteria (1 listed)
- Adult patients with renal cancer undergoing nephrectomy
Key exclusion criteria (1 listed)
- Patients with incomplete data
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 |
|---|---|---|
| NephrectomyPatients underwent nephrectomy | Other | Nephrectomy |
Primary outcome
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy
Time frame: intraoperative period
Pulmonary embolism * Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg * Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
5 secondary outcomes
The incidence of postoperative PE of renal cancer patient undergoing nephrectomy
Time frame: until 7 days after surgery
Length of stay
Time frame: 7 days after surgery
Number of patients with postoperative organ dysfunction
Time frame: 7 days after surgery
Rate of TEE utilization
Time frame: 7 days after surgery
Mortality rate at 30 days postoperative
Time frame: 30 days after 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 16 Mar 2023.
- Background: PubMed 21377083Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011.
- Results publication: PubMed 8212439Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l.
- Results publication: PubMed 17113889Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026.
- Results publication: PubMed 31072702Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15.
- 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.
Aphichat Suphathamwit, M.D. principal investigator
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
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 Pulmonary Embolism and Renal Cell Carcinoma, run by Mahidol University at 1 site in Thailand.
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 16 Mar 2023. 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 Thailand. 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?
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy (time frame: intraoperative period). 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 NCT04402749, which also lists 4 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 16 Mar 2023.