Lactacidemia and ComplicationsNCT04307654
Lactate and Complications in Cytoreduction Surgery for Peritoneal Carcinomatosis
An observational study of Lactacidemia and Complications, run by Hospital General Universitario de Castellón.
Trial summary
Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lactacidemia and Complications
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón
Who may be able to join
- patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón.
Who cannot join
- patients without lactic acid levels in the register.
About this study
Official title: Evaluation of the Relationship Between Lactacidemia and Postoperative Complications After Cytoreduction Surgery for Peritoneal Carcinomatosis
Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis
Read the detailed description
Background. Cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. However, this surgery is associated with important complications. The present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit.
Methods. Retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the General University Hospital of Castellón. All patients were admitted to the critical unit immediately after surgery. Lactacidemia levels at the time of admission and discharge from the critical unit were collected. Post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the Clavien-Dindo classification.
Lactacidemia levels were still significantly higher in this group at the time of discharge.
- Conditions
- Lactacidemia and Complications
- Keywords
- lactic acid, Cytoreductive surgery, postoperative complications
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
complications in patients undergoing cytoreduction surgery during the immediate postoperative period in the Intensive Care Unit (ICU) at the General Hospital of Castellón (HGCS) between 2014 and 2016.
Measured: 2014-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startJan 2014
- Primary completionJun 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactacidemia and ComplicationsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Castellón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Soriano Hervás, Hospital General Universitario de Castellón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307654
- Sponsor's protocol ID
- HGCLAC01
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Lactacidemia and Postoperative Complications After Cytoreduction Surgery for Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT04307654
- Acronym / sponsor ID
- HGCLAC01
- Conditions
- Lactacidemia and Complications
- Keywords
- lactic acid, Cytoreductive surgery, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hospital General Universitario de CastellónUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Mar 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.
Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis
Detailed description
Background. Cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. However, this surgery is associated with important complications. The present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit.
Methods. Retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the General University Hospital of Castellón. All patients were admitted to the critical unit immediately after surgery. Lactacidemia levels at the time of admission and discharge from the critical unit were collected. Post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the Clavien-Dindo classification.
Lactacidemia levels were still significantly higher in this group at the time of discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón
Key inclusion criteria (1 listed)
- patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón.
Key exclusion criteria (1 listed)
- patients without lactic acid levels in the register.
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
Postoperative complications
Time frame: 2014-2016
complications in patients undergoing cytoreduction surgery during the immediate postoperative period in the Intensive Care Unit (ICU) at the General Hospital of Castellón (HGCS) between 2014 and 2016.
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 13 Mar 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactacidemia and Complications, run by Hospital General Universitario de Castellón.
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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative complications (time frame: 2014-2016). 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 13 Mar 2020.