Long-term Follow up in Survivors of Critical Illness

NCT04608994 | Unknown

• 1 other identifier: NP2595
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Survivors of critical illness may suffer from persistent physical, cognitive and mental impairments, such as muscle weakness, dysfunction in the memory and executive domains, post-traumatic stress disorders, depression, and anxiety. This syndrome is referred to as Post Intensive Care Syndrome (PICS). This study aims to assess the frequency of impairments, their evolution over time, and to understand the pathogenetic mechanisms and the association between long-term sequelae and acute care events.

Conditions

Post Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (33)

• Medical Research Council (MRC) sum score

  Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (\< 48) and even better in severe weakness (\<36).

  3 months

• Medical Research Council (MRC) sum score

  Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (\< 48) and even better in severe weakness (\<36).

  6 months

• Medical Research Council (MRC) sum score

  Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (\< 48) and even better in severe weakness (\<36).

  12 months

• Dominand Handgrip Test

  Dynamometry will be considered normal if \>11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: \<20% PNV; 20%\<=PNV\< 40%; 40%\<=PNV\< 60%; 60%\<= PNV\< 80%, and \>=80 PNV. \[DOI: 10.1016/j.clnu.2008.04.004\]

  3 months

• Dominand Handgrip Test

  Dynamometry will be considered normal if \>11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: \<20% PNV; 20%\<=PNV\< 40%; 40%\<=PNV\< 60%; 60%\<= PNV\< 80%, and \>=80 PNV. \[DOI: 10.1016/j.clnu.2008.04.004\]

  6 months

• Dominand Handgrip Test

  Dynamometry will be considered normal if \>11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: \<20% PNV; 20%\<=PNV\< 40%; 40%\<=PNV\< 60%; 60%\<= PNV\< 80%, and \>=80 PNV. \[DOI: 10.1016/j.clnu.2008.04.004\]

  12 months

• Six Minutes Walking Test

  Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight

  3 months

• Six Minutes Walking Test

  Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight

  6 months

• SIX Minutes Walking Test

  Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight

  12 months

• Fatigue Severity Scale (FSS)

  The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.

  3 months

• Fatigue Severity Scale (FSS)

  The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.

  6 months

• Fatigue Severity Scale (FSS)

  The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.

  12 months

• Elettromyography

  Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value \<5.26 mV present in both legs was considered as abnormal.

  3 months

• Elettromyography

  Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value \<5.26 mV present in both legs was considered as abnormal.

  6 months

• Elettromyography

  Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value \<5.26 mV present in both legs was considered as abnormal.

  12 months

• Montreal Cognitive Assessment Test (MoCA)

  Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment

  3 months

• Montreal Cognitive Assessment Test (MoCA)

  Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment

  6 months

• Montreal Cognitive Assessment Test (MoCA)

  Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment

  12 months

• Hospital Anxiety and Depression Scale (HADS)

  Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).

  3 months

• Hospital Anxiety and Depression Scale (HADS)

  Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).

  6 months

• Hospital Anxiety and Depression Scale (HADS)

  Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).

  12 months

• The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD \>32 is strongly associated with the presence of PTSD.

  3 months

• The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD \>32 is strongly associated with the presence of PTSD.

  6 months

• The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD \>32 is strongly associated with the presence of PTSD.

  12 months

• Insomnia Severity Index (ISI)

  Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).

  3 months

• Insomnia Severity Index (ISI)

  Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).

  6 months

• Insomnia Severity Index (ISI)

  Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).

  12 months

• The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.

  3 months

• The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.

  6 months

• The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.

  12 months

• Barthel Index (BI)

  BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (\<20).

  3 months

• Barthel Index (BI)

  BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (\<20).

  6 months

• Barthel Index (BI)

  BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (\<20).

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll all patients admitted to the ICUs with SARS-CoV-2 pneumonia and ARDS.

You may qualify if:

• \- All COVID-19 patients admitted to the ICUs of the Spedali Civili University Hospital in Brescia, Italy.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Università degli Studi di Brescia: collaborator

Study Sites (1)

ASST- Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Related Publications (1)

• Latronico N, Peli E, Calza S, Rodella F, Novelli MP, Cella A, Marshall J, Needham DM, Rasulo FA, Piva S; LOTO Investigators. Physical, cognitive and mental health outcomes in 1-year survivors of COVID-19-associated ARDS. Thorax. 2022 Mar;77(3):300-303. doi: 10.1136/thoraxjnl-2021-218064. Epub 2021 Sep 29.

  PMID: 34588274 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 30, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)