SepsisPTMVPNCT03406494
Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
A study testing Early multicomponent physical therapy program in people with Sepsis, run by Zhujiang Hospital.
Trial summary
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Early multicomponent physical therapy program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.
- 16 ≤ age ≤ 75 years.
- Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.
- Ability to obtain informed consent from patient or proxy.
Who cannot join
- acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).
- active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).
- severe thoracic or abdominal trauma.
- acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.
- drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.
- known pregnancy.
Show all 10Show fewer
- malignant tumor, cachexia, end stage of chronic illness.
- contraindications to rehabilitation therapy.
- inability to obtain an informed consent from patient or a proxy.
- any other factors such as fractures or limb malformation, that would prevent response to physical exercise or cause injury to the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Southern Medical University Clinical Research Project Initiative：Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.
Read the detailed description
The study is a prospective, multi-center, assessor-blinded, randomized controlled trial and will be conducted in 9 medical ICUs at 7 tertiary hospitals in Southern China. Mechanically ventilated septic patient admitted into ICU will be screened for eligibility into the study. When medically stable, patients randomize into the intervention group will receive a multi-component PT. The PT program is designed to counteract ICUAW, delirium, DD and acute GI injury, and consists of 5 consecutive sessions including positioning, extremities muscle strength training, respiratory muscle strength training, neuromuscular electrical stimulation (NMES) and gut rehabilitation. Each PT session will last for 30 minutes and be provided once daily, 5 days per week, and tailored for each individual subject. PT intervention will continue throughout patient's ICU stay or the primary endpoint is reached. The primary outcome will be the ICU 28-day all-cause mortality, and the secondary outcome measures, e.g., incidences or duration of ICUAW, delirium, DD and acute GI injury, mechanical ventilation outcomes (ventilator dependence, ventilator-free days), adverse events, restoration to independent functional status and long-term survival, will be assessed at preset time points of interviews during periods of treatment and 1-year follow-up after discharge from hospital. The total in-hospital and re-hospitalization costs in the intervention group will be also analyzed and compared to control group to assess the cost-effectiveness of the rehabilitation program.To our knowledge, this study is the first randomized controlled trial examining the efficacy and safety of a multi-component PT program in critically ill sepsis patients on ventilator. Given that rehabilitation is not a routine therapy across most ICUs in China, If this PT program is found to be of mortality benefit, it will provide an alternative non-pharmaceutical approach to deal with these lethal ICU-related complications and reduce the subsequent death. It will also provide useful information for clinical decision and local medical policies making, as well as identifying sepsis patient population who might best benefit from early rehabilitation program.
- Conditions
- Sepsis
- Being tested
- Early multicomponent physical therapy program
- Keywords
- sepsis, critical illness, intensive care unit, mechanical ventilation, rehabilitation, mortality, physical function, health-related quality of life
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early multicomponent physical therapy programOther
- Positioning (upright bed standing; turning, moving on bed).
- Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling).
- Respiratory muscle training (supine abdominal breathing training).
- Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris).
- Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Early multicomponent physical therapy program plus sepsis standard therapy Receives: Other: Early multicomponent physical therapy program |
| control group | No intervention | Sepsis standard therapy, including early initiation of intravenous antibiotics, infection source debriding, appropriate fluid therapy, minimum sedation, protocolized weaning procedure, blood glucose control and early enteral feeding, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU 28-day mortality
Sepsis or non-sepsis related death, undetermined cause of death.
Measured: Through 28-day study period in the ICU.
Secondary outcomes (10)
Incidence of ICU-required weakness
Using the Medical Research Council (MRC) Score for Muscle Strength to test 12 muscle groups in upper extremities (wrist flexion, elbow flexion, shoulder abduction) and lower extremities (dorsiflexion, knee extension, hip flexion). The MRC sum score ranges from 0 (complete paralysis) to 60 (full strength) as determined by manual muscle testing (MMT), which grades muscle strength from 0 (paralysis) to 5 (normal muscle strength) in each muscle group tested. Patient with a MRC sum score of < 48 or a mean MRC score of < 4 per muscle group will be considered to have ICUAW. If measurement is impossible at recruitment, patient will be deemed as without ICUAW by a Barthel Index score > 60, which ranges from 0 (complete dependence) to 100 (complete independence), collected from a proxy reflecting baseline independent functional status 2 weeks prior to critical illness.
Measured: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of delirium
Acute cerebral dysfunction with altered mental status, inattention, and either disordered thinking or an altered level of consciousness as determined by the Confusion Assessment Method for the ICU (CAM-ICU). If assessment is impossible at recruitment, patient will be considered without delirium by absence of a history of insanity collected from a proxy reflecting baseline mental status 2 weeks prior to critical illness.
Measured: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of diaphragmatic dysfunction
Maximum negative inspiratory pressure (PImax) less than - 80 cm H2O is usually considered to have clinically important inspiratory muscle weakness. Measurements will be performed by using inspiratory hold key on ventilator (intubated patient) or a one-way exhalation valve placed on the opening of mouth (extubated patient). Patient will be instructed to perform maximal inspiratory efforts for 20 seconds against occluded airway at functional residual lung volume (FRC), and change in pressure be recorded by an external data acquisition system (Powerlab/16sp ML795, Australia ADInstruments) through a physiological pressure sensor (MLT 844, Australia ADInstruments) connected to the opening of endotracheal tube or the valve. The signal sampling frequency will be set at 100 Hz and low-pass filtering frequency at 20 Hz. The signal collected will be digitalized and analyzed in a manner of time-domain, and the PImax be recorded after 3 repetitions.
Measured: Assessed on the day of first try to wean from ventilator, repeated on the days of ICU discharge and hospital discharge, with an average of 1 month.
Incidence of acute gastrointestinal injury
Malfunctioning of the GI tract in critically ill patients due to their acute illness, distinguished and graded by severity of GI symptoms (e.g., feeding intolerance, vomiting, diarrhoea, paralysis, high gastric residual volumes (HGRVs). Acute gastrointestinal injury (AGI) grade I: increased risk to develop GI dysfunction or failure; AGI grade II: GI dysfunction (interventions required); AGI grade III: GI failure (GI function cannot be restored with interventions); AGI grade IV: dramatically manifesting GI failure.
Measured: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Ventilator dependence
Referred to one of the following categories: difficult weaning: fail initial weaning and require up to 3 spontaneous breath test (SBT) or ≤7 days to achieve success; delayed weaning: fail at least 3 weaning attempts or require > 7 days to weaning after the first SBT; prolonged mechanical ventilation (PMV): requiring ventilator support for more than 21 days.
Measured: Number of days required to weaning after the first try, number of days on ventilator, assessed within an average of 3 weeks.
Adverse events
Unexpected physiologic response or patient complaints to physical exercise, e.g., more than 20% variability in rest heart rate; 110 mmHg < mean arterial pressure < 60 mmHg; decremental pulse oximetry < 90%; severe dyspnea as determined by the Modified Borg Dyspnea Scale > 4 (ranged from 0-10, indicative of dyspnea degree from just noticeable to maximum); patient-ventilator asynchrony; altered mentation; catheters or tubes displacement; documented organ damage; accidental death.
Measured: Through physical therapy periods, an average of 1 month.
Length of stay
Number of days spent in the ICU or hospital.
Measured: From admission to ICU discharge and hospital discharge, estimated between 4 to 6 weeks.
Independent functional status
Referred to ability to perform 10 activities of daily living (ADL's), including eating, transfer from bed to chair, dressing, toileting, bathing, grooming, walking, stair climbing, maintaining continence. Independent functional status is determined by a Barthel Index Score > 60, which ranged from 0 (complete dependence) to 100 (complete independence).
Measured: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
Health-related quality of life (HRQOL)
Evaluated by using the mandarin version Short-Form-36 Questionnaire translated by the Zhejiang University, China., consisting of eight domains (e.g., physical function (PF), role limitations due to physical problems (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role limitations due to emotional problems (RE), mental health (MH). The combined score for each domain is obtained by summing score of each item contained in the domain and directly converted into a 0-100 score scale using the Likert method of summated ratings. A score scale of zero is equivalent to maximum disability and 100 equals to the best possible health state.
Measured: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
One-year mortality
All-cause death during 1-year follow-up after hospital discharge.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startMar 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, assessor-blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China
- Responsible party
- Principal investigator, Wang Hua, Zhujiang Hospital
- Investigators
- Yan Zhang, Study director, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406494
- Sponsor's protocol ID
- LC2016PY036
- Acronym
- PTMVP
- Status last verified
- Jan 2018
- First submitted
- 25 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
PubMed 28101605Zhang SW, Wang H, Su Q, Wang BE, Wang C, Yin CH; MODS Research Group. [Clinical epidemiology of 1,087 patients with multiple organ dysfunction syndrome]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2007 Jan;19(1):2-6. Chinese.
PubMed 17207352Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
PubMed 23984731Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4.
PubMed 15090974Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
PubMed 24638143Murphy CV, Schramm GE, Doherty JA, Reichley RM, Gajic O, Afessa B, Micek ST, Kollef MH. The importance of fluid management in acute lung injury secondary to septic shock. Chest. 2009 Jul;136(1):102-109. doi: 10.1378/chest.08-2706. Epub 2009 Mar 24.
PubMed 19318675Zhou J, Tian H, Du X, Xi X, An Y, Duan M, Weng L, Du B; for China Critical Care Clinical Trials Group (CCCCTG). Population-Based Epidemiology of Sepsis in a Subdistrict of Beijing. Crit Care Med. 2017 Jul;45(7):1168-1176. doi: 10.1097/CCM.0000000000002414.
PubMed 28422777Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624MacIntyre NR. The ventilator discontinuation process: an expanding evidence base. Respir Care. 2013 Jun;58(6):1074-86. doi: 10.4187/respcare.02284.
PubMed 23709201Thille AW, Cortes-Puch I, Esteban A. Weaning from the ventilator and extubation in ICU. Curr Opin Crit Care. 2013 Feb;19(1):57-64. doi: 10.1097/MCC.0b013e32835c5095.
PubMed 23235542Chang AT, Boots RJ, Brown MG, Paratz J, Hodges PW. Reduced inspiratory muscle endurance following successful weaning from prolonged mechanical ventilation. Chest. 2005 Aug;128(2):553-9. doi: 10.1378/chest.128.2.553.
PubMed 16100137Vincent JL, Shehabi Y, Walsh TS, Pandharipande PP, Ball JA, Spronk P, Longrois D, Strom T, Conti G, Funk GC, Badenes R, Mantz J, Spies C, Takala J. Comfort and patient-centred care without excessive sedation: the eCASH concept. Intensive Care Med. 2016 Jun;42(6):962-71. doi: 10.1007/s00134-016-4297-4. Epub 2016 Apr 13.
PubMed 27075762De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328Schweickert WD, Hall J. ICU-acquired weakness. Chest. 2007 May;131(5):1541-9. doi: 10.1378/chest.06-2065.
PubMed 17494803
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southern Medical University Clinical Research Project Initiative：Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
- ClinicalTrials.gov ID
- NCT03406494
- Acronym / sponsor ID
- PTMVP / LC2016PY036
- Conditions
- Sepsis
- Keywords
- sepsis, critical illness, intensive care unit, mechanical ventilation, rehabilitation, mortality, physical function, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Southern Medical University, China
- Study start
- Mar 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.
Detailed description
The study is a prospective, multi-center, assessor-blinded, randomized controlled trial and will be conducted in 9 medical ICUs at 7 tertiary hospitals in Southern China. Mechanically ventilated septic patient admitted into ICU will be screened for eligibility into the study. When medically stable, patients randomize into the intervention group will receive a multi-component PT. The PT program is designed to counteract ICUAW, delirium, DD and acute GI injury, and consists of 5 consecutive sessions including positioning, extremities muscle strength training, respiratory muscle strength training, neuromuscular electrical stimulation (NMES) and gut rehabilitation. Each PT session will last for 30 minutes and be provided once daily, 5 days per week, and tailored for each individual subject. PT intervention will continue throughout patient's ICU stay or the primary endpoint is reached. The primary outcome will be the ICU 28-day all-cause mortality, and the secondary outcome measures, e.g., incidences or duration of ICUAW, delirium, DD and acute GI injury, mechanical ventilation outcomes (ventilator dependence, ventilator-free days), adverse events, restoration to independent functional status and long-term survival, will be assessed at preset time points of interviews during periods of treatment and 1-year follow-up after discharge from hospital. The total in-hospital and re-hospitalization costs in the intervention group will be also analyzed and compared to control group to assess the cost-effectiveness of the rehabilitation program.To our knowledge, this study is the first randomized controlled trial examining the efficacy and safety of a multi-component PT program in critically ill sepsis patients on ventilator. Given that rehabilitation is not a routine therapy across most ICUs in China, If this PT program is found to be of mortality benefit, it will provide an alternative non-pharmaceutical approach to deal with these lethal ICU-related complications and reduce the subsequent death. It will also provide useful information for clinical decision and local medical policies making, as well as identifying sepsis patient population who might best benefit from early rehabilitation program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, multicenter, assessor-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Early multicomponent physical therapy programEarly multicomponent physical therapy program plus sepsis standard therapy |
| control group | No intervention | –Sepsis standard therapy, including early initiation of intravenous antibiotics, infection source debriding, appropriate fluid therapy, minimum sedation, protocolized weaning procedure, blood glucose control and early enteral feeding, etc. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.
- 16 ≤ age ≤ 75 years.
- Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.
- Ability to obtain informed consent from patient or proxy.
Key exclusion criteria (10 listed)
- acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).
- active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).
- severe thoracic or abdominal trauma.
- acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.
- drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early multicomponent physical therapy program1. Positioning (upright bed standing; turning, moving on bed). 2. Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling). 3. Respiratory muscle training (supine abdominal breathing training). 4. Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris). 5. Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage). | Other | intervention group |
Primary outcome
ICU 28-day mortality
Time frame: Through 28-day study period in the ICU.
Sepsis or non-sepsis related death, undetermined cause of death.
10 secondary outcomes
Incidence of ICU-required weakness
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of delirium
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of diaphragmatic dysfunction
Time frame: Assessed on the day of first try to wean from ventilator, repeated on the days of ICU discharge and hospital discharge, with an average of 1 month.
Incidence of acute gastrointestinal injury
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Ventilator dependence
Time frame: Number of days required to weaning after the first try, number of days on ventilator, assessed within an average of 3 weeks.
Adverse events
Time frame: Through physical therapy periods, an average of 1 month.
Length of stay
Time frame: From admission to ICU discharge and hospital discharge, estimated between 4 to 6 weeks.
Independent functional status
Time frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
Health-related quality of life (HRQOL)
Time frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
One-year mortality
Time frame: One year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 28101605Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Background: PubMed 17207352Zhang SW, Wang H, Su Q, Wang BE, Wang C, Yin CH; MODS Research Group. [Clinical epidemiology of 1,087 patients with multiple organ dysfunction syndrome]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2007 Jan;19(1):2-6. Chinese.
- Background: PubMed 23984731Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
- Background: PubMed 15090974Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4.
- Background: PubMed 24638143Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
- Background: PubMed 19318675Murphy CV, Schramm GE, Doherty JA, Reichley RM, Gajic O, Afessa B, Micek ST, Kollef MH. The importance of fluid management in acute lung injury secondary to septic shock. Chest. 2009 Jul;136(1):102-109. doi: 10.1378/chest.08-2706. Epub 2009 Mar 24.
- Background: PubMed 28422777Zhou J, Tian H, Du X, Xi X, An Y, Duan M, Weng L, Du B; for China Critical Care Clinical Trials Group (CCCCTG). Population-Based Epidemiology of Sepsis in a Subdistrict of Beijing. Crit Care Med. 2017 Jul;45(7):1168-1176. doi: 10.1097/CCM.0000000000002414.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhang study director
Zhujiang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Early multicomponent physical therapy program in people with Sepsis, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Wang (+86 18665000903, icuwanghua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU 28-day mortality (time frame: Through 28-day study period in the ICU.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406494, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.