- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015755
Palliation of Thirst in ICU Patients
Study Overview
Detailed Description
This study will test the efficacy of an innovative, inexpensive, resource-efficient treatment for thirst -- one of the most pervasive, intense, unrecognized, and under-treated symptoms suffered by critically ill patients in Intensive Care Units (ICUs). The first aim of this single-blinded, randomized clinical trial is to test a non-pharmacologic intervention for thirst in ICU patients. The intervention is a combination therapy treatment (CTT) for thirst that includes the use of sterile water mouth sprays, sterile water swabs, and menthol-based lip and tongue moisturizer. The second aim of the study is to examine demographic, environmental, and health and illness factors that increase an ICU patient's risk profile for thirst. Aim #1 hypotheses: (1) Thirst intensity and distress will decrease significantly in ICU patients who receive a CTT for thirst compared to those who receive research team observation. (2) Subjective (e.g., dry mouth) and objective (e.g., cracked lips) thirst-related characteristics will decrease significantly in ICU patients who receive a CCT for thirst compared to those who receive research team observation. Aim #2 hypotheses: (1) A significant association will be found between presence of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids. (2) A significant association will be found between the intensity of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids.
The sample will be 245 ICU patients in one Experimental and two Control groups. Those with thirst will be randomized to either the Experimental or the Control 1 group. The Experimental group will receive the CTT; the Control 1 group will receive research team observation. The Control 2 group patients who reported no thirst will be compared to the Control 1 group on characteristics associated with the presence and intensity of thirst.
Multilevel linear regression models will be employed to test the difference in the linear change trajectories between the treatment and control groups. Multiple logistic regression analysis and multiple linear regression analysis will be used to determine association of risk factors with the presence and intensity of thirst, respectively.
Results will contribute empirical data needed to stimulate a far overdue nursing practice change for the treatment of thirst in ICUs. Results will also identify a risk profile for thirst that will be an important target for future research of thirst in ICU patients.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143-0610
- University of California San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- must be able to self-report thirst intensity or distress
Exclusion Criteria:
- unable to self-report thirst
- comatose
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: thirst intervention
|
mouth care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thirst intensity
Time Frame: after thirst intervention
|
after thirst intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thirst distress
Time Frame: after thirst intervention
|
after thirst intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kathleen A Puntillo, RN, DNSc, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01NR011825-01 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Thirst
-
Universidade do PortoCompleted
-
Universidade do PortoCompleted
-
Gloucestershire Hospitals NHS Foundation TrustCompletedPostoperative ThirstUnited Kingdom
-
University of Sao PauloUniversidade Estadual de LondrinaCompleted
-
Universidade Estadual de LondrinaCompleted
-
Universidade do PortoCompleted
-
National Taiwan University HospitalCompletedAnesthesia and ThirstTaiwan
-
University of Sao PauloUniversidade Estadual de LondrinaUnknownThirst | Perioperative NursingBrazil
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Universidade Estadual de LondrinaCompleted
Clinical Trials on combined therapy treatment
-
Stanford UniversityNational Institutes of Health (NIH)CompletedAnorexia NervosaUnited States
-
University of JaenCompleted
-
Hangzhou Medical CollegeRecruiting
-
Hitit UniversityCompleted
-
Peking University Third HospitalRecruiting
-
Tianjin Medical University Cancer Institute and...Not yet recruiting
-
Aristotle University Of ThessalonikiCompleted
-
Taipei Hospital, Ministry of Health and WelfareRecruiting
-
Oslo University HospitalRecruiting