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

• ClinicalTrials.gov Identifier: NCT06253052
• Recruitment Status: Not yet recruiting
• First Posted: February 12, 2024
• Last Update Posted: February 12, 2024
• Sponsor: Wuerzburg University Hospital
• Information provided by (Responsible Party): Wuerzburg University Hospital

Tracking Information

• First Submitted Date: January 5, 2024
• First Posted Date: February 12, 2024
• Last Update Posted Date: February 12, 2024
• Estimated Study Start Date: April 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2024)

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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 9, 2024)

• 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
• Fluid fasting time [ Time Frame: Prior to induction of anesthesia ]
  Actual fluid fasting time in hours
• 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.
• CAM-ICU [ Time Frame: 2 hours after end of surgery ]
  Confusion Assessment Method for the Intensive Care Unit.
• 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)
• 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 anesthesiawill be reported.
• 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.
• 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.
• 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.
• Vasopressor [ Time Frame: Within 15 minutes after induction of anesthesia ]
  Use of Vasopressors
• 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
• 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)
• 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.
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
• Official Title: A Pilot Study to Test Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Anesthesia
• Thirst; Due to Deprivation of Water
• Aspiration

Intervention

• 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.

Study Arms

• 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.
  Intervention: Behavioral: Additional pre-OP-visit
• Experimental: Experimental intervention
  Patients should not involuntarily fast fluids for longer than 30 min.
  Interventions:

  • Behavioral: Additional pre-OP-visit
  • Behavioral: Liberal fasting regime

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: February 9, 2024): 174
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Tobias E Haas, Dr.; +49 931 201 ext 30541; haas_t1@ukw.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT06253052
• Other Study ID Numbers: HYDRATE
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wuerzburg University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Wuerzburg University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Wuerzburg University Hospital
• Verification Date: February 2024