DehydrationDEHYDNCT03788070
Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
An observational study of Dehydration and Postoperative Nausea and Vomiting, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration, Postoperative Nausea and Vomiting, Postoperative Complications
- How many people
- 188 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2019to 30 Mar 2020
- 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: The project population will be all patients undergoing major urologic surgery at the Department of Urology, Inselspital Bern, meeting the inclusion criteria. The number of participants depends on the amount of surgeries of patients meeting the inclusion criteria taking place during the inclusion period of 365 days.
Who may be able to join
- >18 years old
- Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal lymphadenectomy)
- Standard procedure planned
- Standard perioperative management planned
- Informed consent
Who cannot join
- Preoperative iv-fluids
- Pregnancy (which is a contraindication to this type of surgery per se)
- Inability to give informed consent (e.g. severe psychiatric disorder, dementia)
- Inability to complete the Quality of Recovery (QoR) questionnaire
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more postoperative complications.
Read the detailed description
The information about the impact of preoperative dehydration on postoperative outcome is conflicting. One of the reported difficulties of the studies in this field is to get adequate power for statistical significance. The incidence of preoperative dehydration in different surgical populations has been reported in about one third of patients. The prevalence in the urologic population is not known.
This is a monocentric observational study with no study intervention. The goal is to consecutively include all patients undergoing major urologic surgery during 365 days who meet the inclusion criteria to assess the prevalence of preoperative dehydration in elective major abdominal urologic surgery when the standard operation procedures of the University Hospital Bern are applied.
- Medical subject headings
- Dehydration, Postoperative Nausea and Vomiting, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Dehydration at Induction of Anesthesia
Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.
Measured: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery
Secondary outcomes (6)
Postoperative Nausea and Vomiting (PONV)
Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.
Measured: 6 hours, 24 hours and 48 hours postoperatively
Gastrointestinal function (flatus/defecation) postoperatively
Time of first flatus or defecation
Measured: 24 hours and 48 hours postoperatively
Renal function postoperatively
Creatinine 6, 24 and 48 hours postoperatively.
Measured: 6 hours, 24 hours and 48 hours postoperatively
Fluid balance
Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.
Measured: within 24 hours postoperatively
Complications within hospitalization
Number of complications according to a prospective list
Measured: within hospital stay, expected to be within 2 weeks postoperatively
Quality of recovery
Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150 (0 worst possible, 150 best possible), is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start12 Feb 2019
- Primary completion16 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas M Löffel, M.D., Principal investigator, Inselspital University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788070
- Sponsor's protocol ID
- LOLD 01-19
- Acronym
- DEHYD
- Status last verified
- May 2020
- First submitted
- 19 Dec 2018
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
- ClinicalTrials.gov ID
- NCT03788070
- Acronym / sponsor ID
- DEHYD / LOLD 01-19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 27 Dec 2018 (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.
The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more postoperative complications.
Detailed description
The information about the impact of preoperative dehydration on postoperative outcome is conflicting. One of the reported difficulties of the studies in this field is to get adequate power for statistical significance. The incidence of preoperative dehydration in different surgical populations has been reported in about one third of patients. The prevalence in the urologic population is not known.
This is a monocentric observational study with no study intervention. The goal is to consecutively include all patients undergoing major urologic surgery during 365 days who meet the inclusion criteria to assess the prevalence of preoperative dehydration in elective major abdominal urologic surgery when the standard operation procedures of the University Hospital Bern are applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The project population will be all patients undergoing major urologic surgery at the Department of Urology, Inselspital Bern, meeting the inclusion criteria. The number of participants depends on the amount of surgeries of patients meeting the inclusion criteria taking place during the inclusion period of 365 days.
Key inclusion criteria (5 listed)
- >18 years old
- Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal lymphadenectomy)
- Standard procedure planned
- Standard perioperative management planned
- Informed consent
Key exclusion criteria (5 listed)
- Preoperative iv-fluids
- Pregnancy (which is a contraindication to this type of surgery per se)
- Inability to give informed consent (e.g. severe psychiatric disorder, dementia)
- Inability to complete the Quality of Recovery (QoR) questionnaire
- Enrolment of the investigator, his/her family members, employees and other dependent persons
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
Prevalence of Dehydration at Induction of Anesthesia
Time frame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery
Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.
6 secondary outcomes
Postoperative Nausea and Vomiting (PONV)
Time frame: 6 hours, 24 hours and 48 hours postoperatively
Gastrointestinal function (flatus/defecation) postoperatively
Time frame: 24 hours and 48 hours postoperatively
Renal function postoperatively
Time frame: 6 hours, 24 hours and 48 hours postoperatively
Fluid balance
Time frame: within 24 hours postoperatively
Complications within hospitalization
Time frame: within hospital stay, expected to be within 2 weeks postoperatively
Quality of recovery
Time frame: 24 hours postoperatively
Results and safety
The study was stopped early (reason given: Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Lukas M Löffel, M.D. principal investigator
Inselspital University Hospital Bern
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 Dehydration and Postoperative Nausea and Vomiting, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 May 2020. 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 Switzerland. 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 stopped early (reason given: Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.). Results are not available in the source record.
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?
Prevalence of Dehydration at Induction of Anesthesia (time frame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery). 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 19 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.