Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000347268
Ethics application status
Approved
Date submitted
2/12/2017
Date registered
8/03/2018
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
RehaSep: health status and quality of life monitored during different rehabilitation procedures in post-sepsis patients
Scientific title
Selected indicators of health status and quality of life monitored during different rehabilitation procedures in post-sepsis patients
Secondary ID [1] 293514 0
National Science Center ID: 316186
Universal Trial Number (UTN)
U1111-1210-6110
Trial acronym
RehaSep
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 305700 0
post-sepsis syndrome (PSS) 305701 0
post intensive care syndrome (PICS) 305702 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304918 304918 0 0
Physiotherapy
Physical Medicine / Rehabilitation 304919 304919 0 0
Other physical medicine / rehabilitation
Inflammatory and Immune System 304920 304920 0 0
Other inflammatory or immune system disorders
Infection 305612 305612 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the rehabilitation and routine diagnostic procedures will be performed by experienced medical specialists at the Ludwik Rydygier Specialist Hospital in Krakow and the specialized microscopy and biochemistry examinations will be done by scientists of the University of Physical Education in Krakow, Poland.
To evaluate the effect of two different rehabilitation treatments on physiological, hematological and biochemical diagnostic indices and the quality of life of sepsis survivors,
at the hospital discharge each patient will be qualified for the study by ward physicians after detailed examinations and individually assigned to one of two experimental groups (C, H) of patients participating in different rehabilitation programs or the control group (K) – with no rehabilitation (which reflects the present medical practice).
Rehabilitation treatment - 36 sessions (3 times a week for 12 weeks):
Arm C: Rehabilitation by cycloergometer training plus diagnostic monitoring;
Rehabilitation training administered by physiotherapist face-to-face will be performed three times a week for 1 h; comprising 15 min warm-up, 30 min cycling in a reclining position and 15 min calming down phase. The exercise intensity will be selected individually according to the result of the initial ECG cycloergometer exercise test supervised by clinical cardiologist.
Arm H: Rehabilitation by Hyperbaric Oxygen Therapy plus diagnostic monitoring:
The patients assigned to group H will be qualified by a experienced HBOT physician after a detailed examination and will undergo 36 sessions of breathing 100% oxygen at 2.5 atm for 90 min seated in a multiplace hyperbaric chamber under medical supervision.
All the participants will be monitored at monthly intervals by multiparameter diagnostic measurements: routine blood tests and specialized hematological and biochemical tests.
At the discharge and after 3 months spirometry and ECG cycloergometer exercise test will be also performed as well as the specialized "Life after Sepsis Survey" questionnaire filled by the patients.
In order to monitor adherence to the interventions the session attendance lists checked by the study personnel will be implemented.
All the data acquired from measurements, observations, medical documentation etc. will be stored in the dedicated data base managed by the project team.
Intervention code [1] 299745 0
Rehabilitation
Intervention code [2] 299746 0
Diagnosis / Prognosis
Comparator / control treatment
Arm K: control group - no treatment; diagnostic monitoring only - comprising ECG exercise tests, spirometry and blood tests performed with the same setting and timing as for the C and H intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 304111 0
Blood test composite outcome - changes of hematological and biochemical diagnostic indices: Complete Blood Count, WBC differential, blood smear, Leukocyte microscopic examination, Acid-Base Balance, Electrolytes, Ca, Mg, Hepatic Function Panel, Renal Function Panel, urate, CRP, lactate, 25-OH-vitamin D, fibrinogen, INR, aPTT, myeloperoxidase, glutathione, Total Oxidative Status, Total Antioxidative Capacity.
Timepoint [1] 304111 0
Baseline (at hospital discharge), and at 1, 2, and 3 months (primary timepoint) after intervention commencement.
Primary outcome [2] 304112 0
Physiological capacity composite outcome - changes of physiological indices measured by:
ECG cycloergometer exercise test (ECG, HR, blood pressure, time to exhaustion, total work [kJ]) and spirometry (FEV 1, FVC, PEF, TPEF, FET).
Timepoint [2] 304112 0
Baseline (at hospital discharge) and at 3 months (primary timepoint) after intervention commencement.
Primary outcome [3] 304113 0
Change in the quality of life as assessed with specialized "Life after Sepsis Survey" questionnaire.
Timepoint [3] 304113 0
Baseline (at hospital discharge) and at 3 months (primary timepoint) after intervention commencement.
Secondary outcome [1] 341019 0
Mortality rate of study participants as compared to the rate for sepsis survivors population.
Timepoint [1] 341019 0
3 months after hospital discharge.
Secondary outcome [2] 341020 0
Hospital readmission number of study participants as verified by medical records.
Timepoint [2] 341020 0
3 months after hospital discharge.

Eligibility
Key inclusion criteria
Documented episode of sepsis (according to the SEPSIS-3 definition)
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sepsis with traumatic, oncology or burn injury background;
- requiring palliative care;
- who are psychiatric or with intellectual disability, unable to cooperate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study participants - sepsis survivors will comprise 3 groups of about 20 patients per group, which will be compared taking into account all the planned physiological and analytical measurements. The results will be analyzed using the adequate statistical methods.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2018
Actual
15/03/2018
Date of last participant enrolment
Anticipated
2/11/2019
Actual
Date of last data collection
Anticipated
2/02/2020
Actual
Sample size
Target
60
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 9408 0
Poland
State/province [1] 9408 0
Malopolska

Funding & Sponsors
Funding source category [1] 298131 0
Government body
Name [1] 298131 0
National Science Centre
Country [1] 298131 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
Al. Jana Pawla II 78, 31-571 Krakow
Country
Poland
Secondary sponsor category [1] 297211 0
None
Name [1] 297211 0
Address [1] 297211 0
Country [1] 297211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299151 0
Regional Medical Chamber in Krakow
Ethics committee address [1] 299151 0
ul. Krupnicza 11a, 31-123 Krakow
Ethics committee country [1] 299151 0
Poland
Date submitted for ethics approval [1] 299151 0
27/11/2015
Approval date [1] 299151 0
11/01/2016
Ethics approval number [1] 299151 0
136/KBL/OIL/2015

Summary
Brief summary
The aim of the planned study is to evaluate the effect of two different rehabilitation treatments on physiological, hematological and biochemical diagnostic indices and the quality of life of sepsis survivors.
The study will be conducted with 60 patients with a history of hospitalizations for sepsis. They will be assigned to three groups: control group - with no rehabilitation (which reflects the present medical practice), and two experimental groups of patients participating in 3-month diagnostically monitored rehabilitation programs - either as the aerobic training on cycloergometer in a reclining position or in the form of the hyperbaric oxygen therapy.
Physiological, hematological and biochemical parameters which indicate the state and function of the immune system, oxidative stress level and degree of post-sepsis organ damage/recovery will be assessed in each patient after completion of clinical therapy of sepsis and in the following three months.
In all of the patients respiratory function tests (spirometry) and regular ECG cycloergometer exercise testing will be carried out in order to assess their physical capacity and/or the results of rehabilitation.
In addition, when leaving hospital and after 3 months, each patient will be surveyed with the specialized quality of life questionnaire "Life after Sepsis Survey".
In spite of the enormous achievements of modern medicine neither the specific diagnostic methods, nor the standards for rehabilitation of the patients have been introduced yet. As a result, high mortality, frequent hospital readmissions and a profound reduction in the quality of life occur in sepsis survivors.
The significance of rehabilitation for post-sepsis patients as the key to their recovery is strongly expressed as well as the need of new research to elucidate long-term functional
impairments is highly encouraged.
The results of this study will be probably the first-of-its kind in science.
A comparison of two distinct forms of intervention used as rehabilitation treatments will allow for better understanding of the changes in patients' organisms during recovery after sepsis.
The new knowledge gained will constitute the starting point for the next stage - the applied research aimed at selection of the most effective rehabilitation methods. They prepare the ground for the future implementation of the appropriate procedures into the medical practice that will bring the diverse economic and social benefits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79466 0
A/Prof Zbigniew Szygula
Address 79466 0
University of Physical Education in Krakow
Al. Jana Pawla II 78, 31-571 Krakow
Country 79466 0
Poland
Phone 79466 0
+48126869010
Fax 79466 0
Email 79466 0
[email protected]
Contact person for public queries
Name 79467 0
A/Prof Zbigniew Szygula
Address 79467 0
University of Physical Education in Krakow
Al. Jana Pawla II 78, 31-571 Krakow
Country 79467 0
Poland
Phone 79467 0
+48126869010
Fax 79467 0
Email 79467 0
[email protected]
Contact person for scientific queries
Name 79468 0
A/Prof Zbigniew Szygula
Address 79468 0
University of Physical Education in Krakow
Al. Jana Pawla II 78, 31-571 Krakow
Country 79468 0
Poland
Phone 79468 0
+48126869010
Fax 79468 0
Email 79468 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExploration of Different Rehabilitation Routes for Sepsis Survivors with Monitoring of Health Status and Quality of Life: RehaSep Trial Protocol.2019https://dx.doi.org/10.1007/s12325-019-01047-9
N.B. These documents automatically identified may not have been verified by the study sponsor.