Intraoperative AnuriaNCT01703442
Intraoperative Anuric Episodes in Patients Undergoing Laparotomy
An observational study of Intraoperative Anuria, run by Claudia Spies at 1 site in Germany.
Trial summary
A single-center prospective observational study. This study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intraoperative Anuria
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Sep 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin.
Who may be able to join
- Offered patient information and written informed consent
- Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour
Who cannot join
- Patients with relapse Ovarian Cancer
- Patients aged less than 18 years
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
Show all 19Show fewer
- (Unclear) history of alcohol or substances disabuse
- Coworker of the Charité
- Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalisation
- Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
- Neurological or psychiatric disease at the beginning of hospitalisation
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalisation
- American Society of Anaesthesiologists (ASA) classification greater than IV
- Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation
- Pulmonal oedema in thorax x-ray at the beginning of hospitalisation
- History of intracranial hemorrhage within one year before participation in the study
- Conditions following venous thrombosis within the last three years before study inclusion
- Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
- Diabetes mellitus with signs of severe neuropathy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Berlin, State of Berlin, 13353
About this study
Official title: Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer
A single-center prospective observational study. This study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome.
Primary hypothesis:
Read more
- Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are phases of temporary anuria.
Secondary hypothesis:
- Perioperative anuric phases are directly associated to the postoperative increase of NGAL (neutrophil gelatinase-associated lipocalin) and creatinine
- Perioperative renal dysfunction is directly associated to postoperative complications and functional recovery of patients
- A response of urine flow to a standardized postoperative diuretic bolus can identify patients who benefit from a pharmaceutical fluid mobilization
- Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the methods for the measurement of stroke volume of the heart differ
- Conditions
- Intraoperative Anuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | Perioperative primary epithelial ovarian cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exact measurement of urine production
Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)
Measured: During the operation and in the 72-hour postoperative sample period
Secondary outcomes (13)
Exact measurement of urine production
Exact measurement of urine production (amount in milliliter)
Measured: During the operation and in the 72-hour postoperative sample period
Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine
Parameters from blood sample
Measured: During the operation and in the 72-hour postoperative sample period
Hemodynamic parameters
Measured: During the operation
Blood loss
Measured: During the operation
Depth of Anesthesia
Measuring depth of Anesthesia by Bispectral Index Monitoring
Measured: During the operation
Organ dysfunctions
Measured: During the operation and in the 72-hour postoperative sample period
Postoperative pain
Measured: In the 72-hour postoperative sample period
Body weight development
Measured: In the 72-hour postoperative sample period
Duration until fulfilment of hospital discharge criteria
Measured: Participants will be followed for the duration of an expected average of 4 weeks
ICU and hospital length of stay
Measured: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
Quality of life and functional status
Measured: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks
Inflammatory parameters
Measured: In the 72-hour postoperative sample period
Amount of vasopressors
Measured: During the operation and in the 72-hour postoperative sample period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startAug 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative AnuriaStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703442
- Sponsor's protocol ID
- EPERIA
- Status last verified
- Aug 2016
- First submitted
- 24 Sep 2012
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01703442
- Acronym / sponsor ID
- EPERIA
- Conditions
- Intraoperative Anuria
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Oct 2012 (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.
A single-center prospective observational study. This study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome.
Primary hypothesis:
- Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are phases of temporary anuria.
Secondary hypothesis:
- Perioperative anuric phases are directly associated to the postoperative increase of NGAL (neutrophil gelatinase-associated lipocalin) and creatinine
- Perioperative renal dysfunction is directly associated to postoperative complications and functional recovery of patients
- A response of urine flow to a standardized postoperative diuretic bolus can identify patients who benefit from a pharmaceutical fluid mobilization
- Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the methods for the measurement of stroke volume of the heart differ
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | –Perioperative primary epithelial ovarian cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin.
Key inclusion criteria (2 listed)
- Offered patient information and written informed consent
- Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour
Key exclusion criteria (19 listed)
- Patients with relapse Ovarian Cancer
- Patients aged less than 18 years
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
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
Exact measurement of urine production
Time frame: During the operation and in the 72-hour postoperative sample period
Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)
13 secondary outcomes
Exact measurement of urine production
Time frame: During the operation and in the 72-hour postoperative sample period
Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine
Time frame: During the operation and in the 72-hour postoperative sample period
Hemodynamic parameters
Time frame: During the operation
Blood loss
Time frame: During the operation
Depth of Anesthesia
Time frame: During the operation
Organ dysfunctions
Time frame: During the operation and in the 72-hour postoperative sample period
Postoperative pain
Time frame: In the 72-hour postoperative sample period
Body weight development
Time frame: In the 72-hour postoperative sample period
Duration until fulfilment of hospital discharge criteria
Time frame: Participants will be followed for the duration of an expected average of 4 weeks
ICU and hospital length of stay
Time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
Quality of life and functional status
Time frame: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks
Inflammatory parameters
Time frame: In the 72-hour postoperative sample period
Amount of vasopressors
Time frame: During the operation and in the 72-hour postoperative sample period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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.
Claudia Spies, MD, Prof. study director
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
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 Intraoperative Anuria, run by Claudia Spies at 1 site in Germany.
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 2 inclusion and 19 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: withdrawn, as of the sponsor's last update on 11 Aug 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Exact measurement of urine production (time frame: During the operation and in the 72-hour postoperative sample period). 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 11 Aug 2016; AzTrials last refreshed its copy on 2 Nov 2026.