Diabetes MellitusTHIRSTNCT06527703
An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting
An observational study of Diabetes Mellitus and Hypertension, run by Mater Dei Hospital, Malta at 1 site in Malta.
Trial summary
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Ischaemic Heart Disease
- How many people
- 5,100 participants
- Where
- 1 siteMalta
- Study dates
- 1 Nov 2024to 30 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded
Who may be able to join
- Age ≥ 18 years
- Patients undergoing elective surgery
- Written informed consent
Who cannot join
- Age < 18 years
- Urgent and emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Prospective, Observational, Multi-centre, Cross-sectional Study on the Duration of Pre-operative Liquid Fasting
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
Read more
Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.
The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.
Read the detailed description
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. The investigators have interest and commitment from 12 countries and hope to recruit more hospitals in the coming weeks.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
In the pilot study the investigators conducted a few weeks ago, the average preoperative liquid fasting time was 12 hours instead of the recommended 2 hours. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesise that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed. This will give further insight to colleagues and encourage healthcare professionals to follow the fasting guidelines from the European Society of Anaesthesia and Intensive Care.
The methodology and other details can be found in the study protocol and the other documents. Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres and the target date is the 23rd October 2024.
After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The following data will be collected:
Patient Number:
Informed Consent: ☐ yes ☐ no
Screening for eligibility Age >= 18 years: ☐ yes ☐ no
Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room _________________
Procedure:
General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________
Type of Anaesthesia (choose 1):
GA ☐ Sedation ☐ Regional ☐
Date and Time at which clear fluids were last consumed:_______________________
The questionnaire will last less than 5 minutes.
This questionnaire is very simple and no patient identifiable data will be recorded on the data collection tool.
- Conditions
- Diabetes Mellitus, Hypertension, Ischaemic Heart Disease, Comorbidities and Coexisting Conditions, Fasting, Fasting, Time Restricted
- Being tested
- no intervention
- Keywords
- Preoperative fluid fasting time
- Medical subject headings
- Diabetes Mellitus, Hypertension, Coronary Artery Disease, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Patients have to answer a questionnaire. The following data will be recorded:
Patient Number:
Informed Consent: ☐ yes ☐ no
Screening for eligibility Age >/= 18 years: ☐ yes ☐ no Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no
Time of arrival in the operating room _________________
Procedure:
General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________
Type of Anaesthesia (choose 1):
GA ☐ Sedation ☐ Regional ☐
Date and Time at which clear fluids were last consumed:_______________________
| Study group | Role | What they receive |
|---|---|---|
| preoperative liquid fasting duration in adult patients undergoing elective surgery | Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.
Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded Receives: Other: no intervention | |
| preoperative liquid fasting time | Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.
Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.
Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.
After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
Measured: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mater Dei Hospital, Malta
- Sponsor type
- University, hospital or other
- Collaborators
- Puerta de Hierro University Hospital
- Responsible party
- Principal investigator, Anne Marie Camilleri Podesta', Mater Dei Hospital, Malta
- Investigators
- Federico Bilotta, Prof, Principal investigatorAnne Marie Camilleri Podesta, Dr, Principal investigator, Mater Dei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527703
- Sponsor's protocol ID
- ThirstStudy
- Acronym
- THIRST
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD The results from the study will be published
Publications
Camilleri Podesta AM, Sciberras S, Moisa E, Valletta L, Farrugia S, Paal P, Kouki P, Gasiunaite D, Vide S, Varosyan A, Golubovska I, Durnev V, Chkhaidze M, Kuci S, Vujovic B, Bilotta F, Corneci D, Dutu M, Tanase NV, Ionita-Radu F, Hostiuc L, Negoita S, Calu V, Tomescu DR, Droc G, Mirea L, Ene R, Ungureanu RI, Grigorescu BL, Stoian M, Ristescu AI, Lungu O, Blaj M, Razvan AI, Ionescu D, Osoian C, Petrisor C, Bedreag O, Papurica M, Dragoescu A, Novac M, Sava M, Bereanu AS, Vintila BI, Zacheu I, Suditu M, Florea M, Trebuian IC, Latis A, Orban C, Rauhut S, Bornemann-Cimenti H, Eichlseder M, Honnef G, Danninger T, Lang J, Baron J, Kostenberger M, Kovalevska K, Kosslbacher M, Wirnsberger V, Schmid A, Hupfl M, Gotsch S, Karageorgos V, Falara A, Chrona E, Tataki E, Iordanidi E, Gizli A, Tsitoura D, Krauklyte J, Macas A, Bukauskas T, Montalto AA, Sultana MB, Gauci C, Miranda R, Chaves C, Cabral J, Martins C, Mourao J, Varosyan Y, Evansa I, Sarkele M, Trojikj T, Kolevska S, Samadashvili T, Kareli T, Goga M, Visnjic J. Pre-operative liquid fasting practices in twelve European countries: A prospective multicentre cohort study (Thirst study). Eur J Anaesthesiol. 2026 Aug 1;43(8):672-679. doi: 10.1097/EJA.0000000000002347. Epub 2026 Jan 20.
PubMed 41504282
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective, Observational, Multi-centre, Cross-sectional Study on the Duration of Pre-operative Liquid Fasting
- ClinicalTrials.gov ID
- NCT06527703
- Acronym / sponsor ID
- THIRST / ThirstStudy
- Conditions
- Diabetes Mellitus, Hypertension, Ischaemic Heart Disease, Comorbidities and Coexisting Conditions, Fasting, Fasting, Time Restricted
- Keywords
- Preoperative fluid fasting time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,100 participants (actual)
- Lead sponsor
- Mater Dei Hospital, MaltaUniversity, hospital or other
- Collaborators
- Puerta de Hierro University Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 30 Jul 2024 (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 investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.
The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.
Detailed description
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. The investigators have interest and commitment from 12 countries and hope to recruit more hospitals in the coming weeks.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
In the pilot study the investigators conducted a few weeks ago, the average preoperative liquid fasting time was 12 hours instead of the recommended 2 hours. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesise that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed. This will give further insight to colleagues and encourage healthcare professionals to follow the fasting guidelines from the European Society of Anaesthesia and Intensive Care.
The methodology and other details can be found in the study protocol and the other documents. Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres and the target date is the 23rd October 2024.
After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The following data will be collected:
Patient Number:
Informed Consent: ☐ yes ☐ no
Screening for eligibility Age >= 18 years: ☐ yes ☐ no
Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room _________________
Procedure:
General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________
Type of Anaesthesia (choose 1):
GA ☐ Sedation ☐ Regional ☐
Date and Time at which clear fluids were last consumed:_______________________
The questionnaire will last less than 5 minutes.
This questionnaire is very simple and no patient identifiable data will be recorded on the data collection tool.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative liquid fasting duration in adult patients undergoing elective surgery | – | Other: no interventionAdult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded |
| preoperative liquid fasting time | – | Other: no interventionAdult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients undergoing elective surgery
- Written informed consent
Key exclusion criteria (2 listed)
- Age < 18 years
- Urgent and emergency surgery
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 |
|---|---|---|
| no interventionPatients have to answer a questionnaire. The following data will be recorded: Patient Number: Informed Consent: ☐ yes ☐ no Screening for eligibility Age >/= 18 years: ☐ yes ☐ no Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room _________________ Procedure: General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________ Type of Anaesthesia (choose 1): GA ☐ Sedation ☐ Regional ☐ Date and Time at which clear fluids were last consumed:_______________________ | Other | preoperative liquid fasting duration in adult patients undergoing elective surgery, preoperative liquid fasting time |
Primary outcome
The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.
Time frame: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024
Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
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 9 Jul 2025.
- Derived from this study: PubMed 41504282Camilleri Podesta AM, Sciberras S, Moisa E, Valletta L, Farrugia S, Paal P, Kouki P, Gasiunaite D, Vide S, Varosyan A, Golubovska I, Durnev V, Chkhaidze M, Kuci S, Vujovic B, Bilotta F, Corneci D, Dutu M, Tanase NV, Ionita-Radu F, Hostiuc L, Negoita S, Calu V, Tomescu DR, Droc G, Mirea L, Ene R, Ungureanu RI, Grigorescu BL, Stoian M, Ristescu AI, Lungu O, Blaj M, Razvan AI, Ionescu D, Osoian C, Petrisor C, Bedreag O, Papurica M, Dragoescu A, Novac M, Sava M, Bereanu AS, Vintila BI, Zacheu I, Suditu M, Florea M, Trebuian IC, Latis A, Orban C, Rauhut S, Bornemann-Cimenti H, Eichlseder M, Honnef G, Danninger T, Lang J, Baron J, Kostenberger M, Kovalevska K, Kosslbacher M, Wirnsberger V, Schmid A, Hupfl M, Gotsch S, Karageorgos V, Falara A, Chrona E, Tataki E, Iordanidi E, Gizli A, Tsitoura D, Krauklyte J, Macas A, Bukauskas T, Montalto AA, Sultana MB, Gauci C, Miranda R, Chaves C, Cabral J, Martins C, Mourao J, Varosyan Y, Evansa I, Sarkele M, Trojikj T, Kolevska S, Samadashvili T, Kareli T, Goga M, Visnjic J. Pre-operative liquid fasting practices in twelve European countries: A prospective multicentre cohort study (Thirst study). Eur J Anaesthesiol. 2026 Aug 1;43(8):672-679. doi: 10.1097/EJA.0000000000002347. Epub 2026 Jan 20.
- Individual participant dataSharing planned: No. There is no plan to share IPD The results from the study will be published
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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.
Federico Bilotta, Prof principal investigator
Anne Marie Camilleri Podesta, Dr principal investigator
Mater Dei 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 Diabetes Mellitus and Hypertension, run by Mater Dei Hospital, Malta at 1 site in Malta.
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 3 inclusion and 2 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 9 Jul 2025. 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 Malta. 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 primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time. (time frame: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024). 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 NCT06527703, which also lists 1 linked publication.
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 9 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.