Patients Undergoing Any Kind of SurgeryINDIZ_IV_INCT01454258
Indication for Intraoperative Volume Therapy
An observational study of Patients Undergoing Any Kind of Surgery, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Undergoing Any Kind of Surgery
- How many people
- 10,100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: All patients of participating hospitals that will undergo surgery and receive intravenous fluid or volume treatment(cristalloid or colloid) will be included. Participating hospitals are the university teaching hospitals of the Goethe University Hospital
Who may be able to join
- patients undergoing surgery receiving at least one bag of cristalloid or colloid solution
Who cannot join
- decline of participation
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.
- Conditions
- Patients Undergoing Any Kind of Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Different Substitution Solutions Administered
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients Undergoing Any Kind of SurgeryStudies 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
- Cross-sectional
- Enrolment
- 10,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital
- Investigators
- Kai Zacharowski, MD, PhD, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454258
- Sponsor's protocol ID
- INDIZ IV I
- Acronym
- INDIZ_IV_I
- Status last verified
- Aug 2017
- First submitted
- 14 Oct 2011
- Last updated
- 14 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indication for Intraoperative Volume Therapy
- ClinicalTrials.gov ID
- NCT01454258
- Acronym / sponsor ID
- INDIZ_IV_I / INDIZ IV I
- Conditions
- Patients Undergoing Any Kind of Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,100 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of participating hospitals that will undergo surgery and receive intravenous fluid or volume treatment(cristalloid or colloid) will be included. Participating hospitals are the university teaching hospitals of the Goethe University Hospital
Key inclusion criteria (1 listed)
- patients undergoing surgery receiving at least one bag of cristalloid or colloid solution
Key exclusion criteria (1 listed)
- decline of participation
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 Different Substitution Solutions Administered
Time frame: 24h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Kai Zacharowski, MD, PhD principal investigator
Johann Wolfgang Goethe University 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 Patients Undergoing Any Kind of Surgery, run by Johann Wolfgang Goethe University Hospital 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 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 14 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Different Substitution Solutions Administered (time frame: 24h). 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 14 Sep 2017.