Nutrition Timing for Sleep Disruption in ICU Patients

Overseen By Hassan S Dashti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines, Antipsychotics

Disqualifiers: Blind, Pregnant, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflammation and cardiometabolic profiles in postoperative patients in the cardiac surgical ICU on enteral nutrition.

Will I have to stop taking my current medications?

The trial requires that participants do not take benzodiazepines or antipsychotics. If you are on these medications, you would need to stop them to participate.

What data supports the effectiveness of the treatment for Nutrition Timing for Sleep Disruption in ICU Patients?

Research suggests that early enteral nutrition (feeding through a tube directly into the stomach or small intestine) within 24-48 hours can improve clinical outcomes in critically ill patients, which may indirectly support the idea that timing of nutrition could impact recovery and well-being. ^{1 2 3 4 5}

Is time-restricted feeding or chrononutrition generally safe for humans?

The research on time-restricted feeding and chrononutrition suggests that while there are potential benefits in aligning feeding times with natural body rhythms, there is also a risk of intestinal-related complications, especially with early enteral nutrition in critically ill patients. Overall, the safety data is inconclusive due to inconsistent study methods and definitions. ^{1 2 3 6 7}

How does the treatment of nutrition timing for sleep disruption in ICU patients differ from other treatments?

This treatment is unique because it focuses on the timing of enteral nutrition (feeding through a tube) to align with the body's natural circadian rhythms (internal biological clock), which may help improve metabolism and recovery in ICU patients by potentially restoring disrupted sleep and biological patterns. ^{1 6 8 9 10}

Research Team

Hassan S Dashti, Ph.D., R.D.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 who are scheduled for cardiac surgery and will stay in the ICU for more than 48 hours. They must be able to consent and follow study rules. It's not open to those with severe liver or kidney issues, dietary limits that prevent tube feeding, certain brain damage, gut absorption problems, gallbladder disease or pancreatitis, chronic use of specific sedatives or antipsychotics, sensory impairments, pregnant/nursing women, or unsafe conditions for tube feeding.

Inclusion Criteria

I am scheduled for heart surgery and will stay in the ICU for more than 48 hours afterwards.

Able and willing to give consent and comply with study procedures

Exclusion Criteria

I am on long-term medication for anxiety or psychosis.

I have a history of problems absorbing food, or issues with my gallbladder or pancreas.

I do not require dialysis and my liver function score is 7 or less.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either daytime or nighttime cycled enteral feeds for 12 hours, followed by a 24-hour washout period, then switch to the opposite feeding schedule for another 12 hours.

2 days

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for changes in sleep quality, circadian rhythms, inflammation, and cardiometabolic profiles after the treatment phase.

1 week

Treatment Details

Interventions

• Time-of-day of enteral nutrition provision (daytime first)
• Time-of-day of enteral nutrition provision (nighttime first)

Trial Overview The study tests if changing when patients get their tube-fed nutrition (from nighttime to daytime) can improve sleep quality and maintain natural body rhythms while reducing inflammation and improving heart-related health markers in post-surgery ICU patients.

Participant Groups

Group I: Nighttime cycled enteral feeds first Experimental Treatment 1 Intervention

Patients will start nighttime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start daytime cycled enteral feeds for 12 hours.

Group II: Daytime cycled enteral feeds first Experimental Treatment 1 Intervention

Patients will start daytime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start nighttime cycled enteral feeds for 12 hours.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

In a study of 34 individuals aged 52 to 80, those receiving intermittent enteral nutrition showed significantly higher energy expenditure and oxygen consumption compared to those on continuous feeding, indicating a potential advantage of intermittent feeding methods.

Both feeding methods demonstrated circadian variations in energy expenditure and oxygen consumption, suggesting that multiple measurements throughout the day are necessary to accurately assess a patient's nutritional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythm of energy expenditure and oxygen consumption. Leuck, M., Levandovski, R., Harb, A., et al.[2014]

Starting enteral nutrition immediately after admission to the ICU using a nasojejunal tube significantly improves serum albumin and prealbumin levels compared to starting nutrition 24 to 48 hours later, based on a study of 100 critically ill patients.

Initiating enteral nutrition early also leads to shorter ICU stays and ventilator times, while reducing complications like gastric retention and pulmonary infections, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Initiation Time of Enteral Nutrition for Critically Ill Patients: At Admission vs. 24 to 48 Hours after Admission. Yu, A., Xie, Y., Zhong, M., et al.[2022]

In a study of 26 hospitalized patients receiving enteral nutrition (EN), the actual calories delivered were significantly higher (mean 1678 kcal) than those prescribed (mean 1489 kcal), indicating a discrepancy of 5%–21% due to feeding pump inaccuracies.

The results suggest that a volume-based ordering system for EN may provide more accurate delivery compared to the traditional rate-based system, which could improve patient nutrition management in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivered volumes of enteral nutrition exceed prescribed volumes. Walker, RN., Utech, A., Velez, ME., et al.[2017]

After modifying the nutrition support protocol in the ICU, the percentage of patients receiving enteral nutrition (EN) within 72 hours of admission increased significantly from 64% to 88%.

The overall amount of nutrition provided enterally also increased, leading to a marked decline in the use of parenteral nutrition, although the goal of meeting calculated nutrition requirements was achieved later, by Day 7 instead of Day 4.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on nutritional care practice after implementation of a flow chart-based nutrition support protocol in an intensive care unit. Wikjord, K., Dahl, V., Søvik, S.[2021]

Early Enteral Nutrition (EN) initiated within 24-48 hours of ICU admission significantly improves clinical outcomes for critically ill patients, including reduced hospitalization time and lower rates of morbidity and mortality.

Nurse-led protocols for early EN are effective in achieving daily calorie targets, highlighting the importance of timely nutritional support in managing hypercatabolism in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Enteral Nutrition Met Calories Goals Led by Nurse on Improve Clinical Outcome: A Systematic Scoping Review. Koontalay, A., Suksatan, W., Teranuch, A.[2023]

Restoring circadian rhythms in critically ill patients may improve health outcomes and recovery, particularly through interventions like optimizing feeding times to align with individual day-night cycles.

Time-restricted feeding could serve as a potential strategy to enhance immune response by re-establishing circadian patterns, although further research is needed to determine the best approaches for implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and the realignment of biological rhythms: translational opportunities and challenges. Sunderram, J., Sofou, S., Kamisoglu, K., et al.[2021]

This systematic review of 11 studies, including randomized controlled trials and cohort studies, found no significant benefit of early enteral nutrition (EN) on short-term mortality in critically ill sepsis patients.

While early EN was associated with a higher risk of intestinal-related complications, the evidence was inconclusive and highlighted the need for better-defined studies due to inconsistencies and biases in the existing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Early Enteral Nutrition on Clinical Outcomes in Critically Ill Sepsis Patients: A Systematic Review. Moon, SJ., Ko, RE., Park, CM., et al.[2023]

A study of 136,667 adult patients revealed that both post-ICU and non-ICU patients are often inadequately fed, with about two-thirds of those eating less than half a meal not receiving any form of nutritional support like enteral or parenteral nutrition.

Post-ICU patients were 1.3 to 2.0 times more likely to receive nutritional support compared to non-ICU patients, highlighting the need for improved nutritional therapy for all patients, especially those with insufficient food intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More Nutritional Support on the Wards after a Previous Intensive Care Unit Stay: A nutritionDay Analysis in 136,667 Patients. Fischer, A., Veraar, C., Worf, I., et al.[2023]

Circadian rhythms, which influence metabolic processes, are significantly disrupted during critical illness, affecting recovery in the ICU.

While intermittent feeding strategies have been compared to continuous feeding, no clear benefits on metabolic outcomes like glycaemic control or muscle mass have been observed, indicating that more research is needed to understand their impact on circadian rhythms and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent feeding and circadian rhythm in critical illness. Kouw, IWK., Heilbronn, LK., van Zanten, ARH.[2023]

Critically ill patients often experience gastrointestinal dysfunction, and while enteral nutrition is recommended within 24-48 hours, it may not be suitable for those with acute gastrointestinal injury due to potential negative effects on recovery.

The authors suggest implementing trophic feeding after 72 hours as a strategy to partially rest the gut, which could help protect the intestine and improve outcomes for patients with acute gastrointestinal injury during critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut rest strategy and trophic feeding in the acute phase of critical illness with acute gastrointestinal injury. Zhang, D., Li, H., Li, Y., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Circadian rhythm of energy expenditure and oxygen consumption. [2014]

2. Egypt pubmed.ncbi.nlm.nih.gov

Comparison of the Initiation Time of Enteral Nutrition for Critically Ill Patients: At Admission vs. 24 to 48 Hours after Admission. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Delivered volumes of enteral nutrition exceed prescribed volumes. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Effects on nutritional care practice after implementation of a flow chart-based nutrition support protocol in an intensive care unit. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Early Enteral Nutrition Met Calories Goals Led by Nurse on Improve Clinical Outcome: A Systematic Scoping Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and the realignment of biological rhythms: translational opportunities and challenges. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of Early Enteral Nutrition on Clinical Outcomes in Critically Ill Sepsis Patients: A Systematic Review. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

More Nutritional Support on the Wards after a Previous Intensive Care Unit Stay: A nutritionDay Analysis in 136,667 Patients. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Intermittent feeding and circadian rhythm in critical illness. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Gut rest strategy and trophic feeding in the acute phase of critical illness with acute gastrointestinal injury. [2020]