Severe Sepsis or Septic Shock
Conditions
Keywords
sepsis, septic shock, rehabilitation, exercise
Brief summary
We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.
Interventions
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥20; 2. confirmed or suspected infection; 3. two or more among 1)-4) 1) body temperature \>38˚C or \<36˚C 2) heart rate \>90/min 3) respiratory rate \>20/min or PaCO2\<32 mmHg 4) WBC \>12000/mm3, \<4000/mm3, or band forms \>10%; 4. within 48 hours after arriving ER
Exclusion criteria
1. severe functional disability before admission; 2. central nervous system infection; 3. contraindication for exercise rehabilitation according to the investigators' decision; 4. severe medical illness or mental problem or laboratory abnormality which can confound the results; 5. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe functional disability | 6 months after enrollment | We will assess the functional activity with 0-11 score of 6 ADL(walking, dressing, bathing, eating, getting into and out of bed, toileting) and 5 IADL(preparing a hot meal, shopping for groceries, making telephone calls, taking medicines, managing money). If the patient has a score 4 or more, the patient will be considered to have a severe functional disability. |
Countries
South Korea
Outcome results
None listed