Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surg… (NCT02711709) | Clinical Trial Compass
CompletedNot Applicable
Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty
United States53 participantsStarted 2016-04
Plain-language summary
The purpose of this study is to define the natural history and causes of chronic critical illness (CCI) in surgical intensive care patients who have had sepsis. The investigator wants to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of this research study is to define the acute changes in frailty (weakness, slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and performing routine daily functions) after having an infection that is located in the abdominal cavity or torso. The investigator believes having severe infection contributes to acute and permanent changes in these areas, especially in those of advanced age.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admission to the surgery or trauma ICU where clinical care can be managed by surgical critical care guided by standard operating procedures.
* Age ≥18 years
* Diagnosis of sepsis, severe sepsis, or septic shock
* Entrance into the standard-of-care sepsis protocol
* Ability to obtain patient/legally authorized representative informed consent.
Exclusion Criteria:
* Significant traumatic brain injury (evidence of neurologic injury on CT scan and a best Glascow Coma Scale \<8 within 24 hours of injury)
* Refractory shock (i.e., patients who die within 12 hours)
* Alternative or confounding diagnosis causing shock state (e.g., myocardial infarction or pulmonary embolus)
* Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
* Patients deemed to be futile care or have advanced care directives limiting resuscitative efforts such as patient or patient's family who are not committed to aggressive management of the patient's condition. Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. Recurrent, advanced or metastatic cancer).
* Severe Congestive Heart Failure (NY Heart Association Class IV)
* Child-Pugh Class C liver disease or pre-liver transplant.
* Known HIV infection with CD4 count\<200 cells/mm3,
* Organ transplant recipient on immunosuppressive agents
* Known pregnancy
* Inability to obtain informed consent
* Prisoners
* Institutionalized patients
* Chemothe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tracked how often patients developed frailty after surviving intra-abdominal sepsis — using specific tools called the Fried and Rockwood Frailty Criteria — so could you explain what those scores actually measure and whether my current condition would be assessed that way?
2Since this study followed patients at 3, 6, and 12 months after sepsis, what did researchers learn about how quickly frailty can set in after a serious infection like this, and does that change how you'd monitor my recovery?
3The trial focused on something called PICS — Persistent Inflammation, Immunosuppression and Catabolism Syndrome — which can happen after surviving critical illness, so how would you recognize if I were developing that, and what would treatment look like?
4Given that this study is now completed, have the findings changed the standard of care for patients recovering from intra-abdominal sepsis, and is there anything from this research that would apply directly to my situation?
5Because this trial was observational and not testing a specific treatment, are there other active trials or standard therapies targeting PICS or post-sepsis frailty that might be worth discussing as part of my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Fried Frailty Criteria.
Timeframe: Baseline, 3, 6 and 12 months.
2
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Rockwood Frailty Criteria.