Palliation of Thirst in ICU Patients
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|ClinicalTrials.gov Identifier: NCT01015755|
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : March 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Thirst||Behavioral: combined therapy treatment||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||353 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Palliation of Thirst in ICU Patients|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Experimental: thirst intervention||
Behavioral: combined therapy treatment
- Thirst intensity [ Time Frame: after thirst intervention ]
- Thirst distress [ Time Frame: after thirst intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015755
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143-0610|
|Principal Investigator:||Kathleen A Puntillo, RN, DNSc||University of California, San Francisco|