The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients

The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients



Sponsors

Lead Sponsor



Source

Hospital Sao Domingos

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

This prospective observational cohort study will investigate the impact of a bundle of nine
preventive measures (Assessment, prevention and management of pain; spontaneous awaking
trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment,
prevention and management; early mobility; family communication and ICU Diary) on the
incidence and severity of Post-Intensive Care Syndrome (PICS) and clinical outcomes in
critically ill patients

Detailed Description

This is a prospective observational cohort study. It will include all adult patients,
admitted to a surgical ICU (13 beds) and a medical ICU (10 beds), with a length of ICU stay
of at least 2 day, from January 01 to December 31 2018. Patients with severe cognitive
deficits prior to admission, identified by clinical history obtained by the psychology or
through the Mental State Mini Exam (MMSE), traumatic brain injury and stroke patients with
Glasgow coma scale <14, will be excluded. On admission to the ICU, risk factors for PICS will
be identified.

During ICU stay, the patients will be submitted to nine interventions aiming at the
prevention of PICS: Assessment, prevention and management of pain; spontaneous awaking trial;
spontaneous breathing trial; choice of sedation and analgesia; delirium assessment,
prevention and management; early mobility; family communication and ICU Diary. At ICU
discharge, the physical, psychiatric and cognitive components of PICS will be evaluated using
the following tools: FSS-ICU, dynamometry and nutritional indicators (physical component),
HADS (Anxiety and Depression), MOCA (cognitive dysfunction) and PCL -C (posttraumatic stress
disorder). The duration of mechanical ventilation, duration of sedation, ICU LOS and hospital
mortality will also be evaluated. Reassessments will be done 5 days after discharge from the
ICU or at hospital discharge (what happens first) and 3 months after the randomization at the
follow-up clinic. Patients identified with PICS at discharge from the ICU will be compared
with those who did not develop the syndrome. The investigators will specifically evaluate the
percentage of adherence to preventive measures, the presence of risk factors and clinical
outcomes.

Overall Status

Not yet recruiting

Start Date

2018-01-25

Completion Date

2019-05-31

Primary Completion Date

2018-12-31

Phase

N/A

Study Type

Observational [Patient Registry]

Primary Outcome

Measure

Time Frame

Change in Cognitive function
Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Change in Psychiatric function
Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Change in Post-traumatic stress syndrome
Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Change in physical function
Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic

Secondary Outcome

Measure

Time Frame

The duration of mechanical ventilation,
During ICU stay.. Expected average 21 days
Duration of sedation
During ICU stay. Expected average 21 days
ICU LOS
During ICU stay. Up to 30 days
Hospital Mortality
90 days
Physical function
ICU discharge (baseline) and change from baseline at 3 months

Number Of Groups

1

Enrollment

500

Condition


Eligibility

Study Pop

All adult patients, admitted to a surgical ICU (13 beds) and a medical ICU (10 beds), with
a length of ICU stay of at least 2 day, from January 01 to December 31 2018. Patients with
severe cognitive deficits prior to admission, identified by clinical history obtained by
the psychology or through the Mental State Mini Exam (MMSE), traumatic brain injury and
stroke patients with Glasgow coma scale <14, will be excluded.

Sampling Method

Probability Sample

Criteria

Inclusion Criteria: .

- Adult non pregnant patients

- Length of ICU stay of at least 2 days.

Exclusion Criteria:

- Severe cognitive deficits prior to admission.

- Traumatic brain injury with Glasgow coma scale < 14

- Stroke with Glasgow coma scale < 14

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

JOSE R AZEVEDO, MA, PhD
Study Chair
DIRECTOR ICU

Overall Contact

Last Name

JOSE R AZEVEDO, MD, PhD

Phone

+55 98 32168110

Email



Location

Facility

Hospital Sao Domingos
Sao Luis MA 65060-642 Brazil

Location Countries

Country

Brazil


Verification Date

2018-01-01

Lastchanged Date

2018-01-11

Firstreceived Date

2017-12-24

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Hospital Sao Domingos

Investigator Full Name

José Raimundo Araujo de Azevedo

Investigator Title

Director of ICU


Keywords


Has Expanded Access

No

Condition Browse


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

WIDLANI S MONTENEGRO, RN, MS

Phone

+55 9832168110

Email



Reference

Citation

Wunsch H, Angus DC, Harrison DA, Collange O, Fowler R, Hoste EA, de Keizer NF, Kersten A, Linde-Zwirble WT, Sandiumenge A, Rowan KM. Variation in critical care services across North America and Western Europe. Crit Care Med. 2008 Oct;36(10):2787-93, e1-9. doi: 10.1097/CCM.0b013e318186aec8. Review.

PMID

18766102


Citation

Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75. Review.

PMID

21946660


Citation

Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

PMID

24088092


Citation

4. Torres J, Veiga C, Pinto F, et al. Post intensive care syndrome- from risk at ICU admission to 3 months follow-up clinic. Intensive Care Med Experimental 2015, 3 (Suppl 1): A448.


Citation

5. Ramnarain D, Rutten A, Van der Nat G, et al. The impact of post intensive care syndrome in patients surviving the ICU: the downside of ICU treatment. Intensive Care Med Experimental 2015, 3 (Suppl 1): A530.


Citation

de Azevedo JR, Montenegro WS, Rodrigues DP, de C Souza SC, Araujo VF, de Paula MP, Prazeres PH, da Luz Leitão A, Mendonça AV. Long-term cognitive outcomes among unselected ventilated and non-ventilated ICU patients. J Intensive Care. 2017 Feb 17;5:18. doi: 10.1186/s40560-017-0213-4. eCollection 2017.

PMID

28239475


Citation

Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

PMID

20978258



Target Duration

3 Months

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

December 24, 2017

Study First Submitted Qc

January 11, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 11, 2018

Last Update Submitted Qc

January 11, 2018

Last Update Posted

January 12, 2018


ClinicalTrials.gov processed this data on January 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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