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

PICS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398707
• Other study ID #: PICS study
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2018
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• PICS

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	Sao Luis	MA

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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.

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.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	The duration of mechanical ventilation,	The duration of mechanical ventilation in days	During ICU stay.. Expected average 21 days
Secondary	Duration of sedation	Duration of sedation during ICU stay in days	During ICU stay. Expected average 21 days
Secondary	ICU LOS	Length of ICU stay in days	During ICU stay. Up to 30 days
Secondary	Hospital Mortality	Hospital LOS in days	90 days
Secondary	Physical function	Measure of handgrip strength though a high precision dynamometer	ICU discharge (baseline) and change from baseline at 3 months