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

NCT03398707 | Completed DMC

• 1 other identifier: PICS study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

PICS

Keywords

PICs; diagnosis; prevention; outcome

Outcome Measures

Primary Outcomes (4)

• Change in Cognitive function

  Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool,

  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

  Evaluation of psychiatric dysfunction using the HADS (Hospital Anxiety and Depression Scale).

  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

  Identification of post-traumatic stress syndrome through PCL-C (Post-traumatic stress checklist-civilian)

  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

  Evaluation of physical dysfunction through FSS-ICU (Functional status score in the ICU)

  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 Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Adult non pregnant patients
• Length of ICU stay of at least 2 days.

You may not qualify if:

• Severe cognitive deficits prior to admission.
• Traumatic brain injury with Glasgow coma scale \< 14
• Stroke with Glasgow coma scale \< 14

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

Location

Related Publications (7)

• 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.

  PMID: 18766102 BACKGROUND

• 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.

  PMID: 21946660 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• de Azevedo JR, Montenegro WS, Rodrigues DP, de C Souza SC, Araujo VF, de Paula MP, Prazeres PH, da Luz Leitao A, Mendonca 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JOSE R AZEVEDO, MA, PhD

  DIRECTOR ICU

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ICU

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 12, 2018
• Study Start: January 25, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: July 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)