Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients (HYDRATE)

May 20, 2025 updated by: Wuerzburg University Hospital

A Pilot Study to Test Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients

The purpose of this study is to show if - compared to standard practice - allowing adults undergoing surgical procedures under anaesthesia care to drink clear fluids up to a volume of 200 ml between 2 h prior to the operation and the call to operation room (approximately 30 min prior to anaesthesia induction) will decrease patient thirst and increase patient satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tobias E Haas, Dr.
  • Phone Number: 30541 +49 931 201
  • Email: haas_t1@ukw.de

Study Locations

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Wuerzburg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adult patients (≥ 18 years)
  2. American Society of Anesthesiologists (ASA) physical status classification I-III
  3. Undergoing surgical procedure under anaesthesia care: general anaesthesia, regional anaesthesia, combined anaesthesia or monitored anaesthesia care.

The proportion of Patients undergoing general or combined anaesthesia is aimed to exceed 75%

Exclusion Criteria:

  1. Absolute indication for rapid sequence induction including but not limited to:

    1. Bowel obstruction including ileus
    2. Stricture and oesophageal disorders including achalasia
    3. Recent polytrauma or trauma of the upper gastrointestinal tract
    4. Acute abdomen/peritonitis including active gastrointestinal bleeding

  2. Relative indication for (modified) rapid sequence induction includes, but is not limited to:

    1. Symptomatic gastroesophageal reflux disease, independent of food intake and persistent under medical treatment (PPI)
    2. Hiatus hernia or upside down stomach
    3. Upper gastrointestinal tumour
    4. History of upper gastrointestinal surgery (oesophageal, gastric, duodenum, pancreatic)
    5. Medically confirmed gastroparesis
    6. Severe obesity, defined as body mass index ≥ 40 kg/m2
  3. Dysphagia
  4. Renal replacement therapy
  5. Fluid restriction therapy
  6. Pregnancy
  7. Expected need for postoperative mechanical ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
Fasting instructions as given by anaesthesiologist according to national guidelines (6 h solid meal and thick liquids, 2 h clear fluids).
Active Comparator: Instructed guideline adherence
Patients should not involuntarily fast fluids for longer than 2 h.
Behavioral: Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
Experimental: Experimental intervention
Patients should not involuntarily fast fluids for longer than 30 min.
Behavioral: Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
Behavioral: Liberal fasting regime
Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thirst
Time Frame: Prior to induction of anaesthesia
At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)
Prior to induction of anaesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total number of protocol deviations per group
Time Frame: From enrollment until last Follow-up is concluded at up to 48 hours post surgery
Outcome assessment successfully blinded Real fluid fasting time is less than allocated fluid fasting time
From enrollment until last Follow-up is concluded at up to 48 hours post surgery
Fluid fasting time
Time Frame: Prior to induction of anesthesia
Actual fluid fasting time in hours
Prior to induction of anesthesia
RASS
Time Frame: 2 hours after end of surgery
Richmond Agitation Sedation Scale. A scale from -5 to +4 is used. Negative values indicate a sedated state. Positive values indicate an agitated state.
2 hours after end of surgery
CAM-ICU
Time Frame: 2 hours after end of surgery
Confusion Assessment Method for the Intensive Care Unit.
2 hours after end of surgery
Headache
Time Frame: Prior to induction of anesthesia and 2 hours after end of surgery
At any stage after your hospital admission have you had the following: Headache (No/ Yes, moderate/ Yes, severe)
Prior to induction of anesthesia and 2 hours after end of surgery
Change of systolic blood pressure on induction of anesthesia
Time Frame: 5 minutes prior and 15 minutes after induction of anesthesia
The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.
5 minutes prior and 15 minutes after induction of anesthesia
Change of diastolic blood pressure on induction of anesthesia
Time Frame: 5 minutes prior and 15 minutes after induction of anesthesia
The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.
5 minutes prior and 15 minutes after induction of anesthesia
Change of mean arterial pressure on induction of anesthesia
Time Frame: 5 minutes prior and 15 minutes after induction of anesthesia
The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.
5 minutes prior and 15 minutes after induction of anesthesia
Vasopressor
Time Frame: Within 15 minutes after induction of anesthesia
Use of Vasopressors
Within 15 minutes after induction of anesthesia
Blood glucose level
Time Frame: At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)
Blood glucose level
At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)
Intravenous catheter placement
Time Frame: Between admission to the operation room and induction of anesthesia
Number of attempts for placing a (first) peripheral intravenous catheter (only applicable if a peripheral intravenous catheter needs to be placed)
Between admission to the operation room and induction of anesthesia
Postoperative nausea and vomiting
Time Frame: 2 hours after end of surgery
Postoperative nausea and vomiting is a composite endpoint of the following dimensions: Vomiting, retching, nausea, and/or use of rescue medication.
2 hours after end of surgery
Unplanned ICU/IMC
Time Frame: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
Unplanned intensive/intermediate care unit stay due to respiratory complications
From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
Number of Participants with confirmed bronchopulmonary aspiration
Time Frame: From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery
If relevant bronchopulmonary aspiration is suspected, it needs to be confirmed by bronchoscopy or radiology imaging up to 48 hours after anaesthesia procedure
From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery
All cause mortality
Time Frame: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
Death within observation period
From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
Change of heart rate on induction of anesthesia
Time Frame: 5 minutes prior and 15 minutes after induction of anesthesia
The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.
5 minutes prior and 15 minutes after induction of anesthesia
Patient satisfaction
Time Frame: 2 hours after end of surgery
Patient satisfaction, operationalized using the Bauer Satisfaction Questionnaire, includes 10 ordinal items with 3 levels (where higher values indicate unfavourable outcomes), 5 items on a Likert scale with 4 levels (where lower values indicate unfavourable outcomes), and one binary item.
2 hours after end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patrick Meybohm, Prof. Dr., University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
  • Principal Investigator: Tobias E Haas, Dr., University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HYDRATE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings