The pre-symptomatic detection of early extreme response to an infection (sepsis)

A multi-centre study to investigate immune modulators for the early diagnosis of sepsis in patients undergoing major elective surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17375399

Enrollment

4385

Registered

2020-10-28

Start date

2007-11-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediction of sepsis in elective surgery patents Infections and Infestations

Interventions

Demographic and clinical data will be gathered daily along with blood samples for immune modulators and urine samples. Some patients will have a straightforward perioperative course (non-septic group)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 80 years 2. Ability to give written informed consent prior to study participation 3. Patients undergoing elective high-risk surgery (e.g. aortic vascular surgery, cardio-thoracic surgery, colonic surgery, gastrectomy, oesophago-gastrectomy, Whipple’s procedure, biliary or urological procedures) 4. ASA grades 1, 2, 3

Exclusion criteria

Exclusion criteria: 1. Pregnant patients 2. Immunosuppressed patients (e.g. HIV disease, anti-rejection medication)

Design outcomes

Primary

Measure	Time frame
Original primary outcome: 1. Development of sepsis, measured using the “sepsis 2” criteria which is a Systemic Inflammatory Response Syndrome (SIRS) characterised by 2 of the following (measured daily for 7 days after surgery): 1.1. Temperature >38 or 20/min or PCO2 90/min after fluid resuscitation measured by clinical observation 1.4. White cell count >10 or 10% immature forms measured by blood test A clinical adjudication panel sifted blinded patient data (including all relevant patient observations and clinical data) to determine which patients adhered to this criteria and which did not. The definition of the study’s primary outcome (SEPSIS) was later changed to be defined as organ dysfunction (characterised by an increase in daily Sequential Organ Failure Assessment (SOFA) score of 2 or more from one day to the next) caused by an infectious agent. Sufficient clinical data was collected during the study to enable identification of patients who achieved the new “sepsis 3” criteria. The parameters for SOFA score include (measured using standard clinical biochemistry and haematology assays, daily for up to 7 days after surgery): 1.1. Respiratory system function (PO2/FiO2 mmHg/kPa >400 to 150 to 12.0 mg/dl) 1.4. Cardiovascular system function (MAP or medication to maintain MAP) 1.5. Central nervous system function (Glasgow Coma Score) 1.6. Renal system function (Creatinine levels 5.0 mg/dl) 2. Biomarkers in whole blood samples (collected daily for 7 days) of patients who go on to develop sepsis, assessed using gene expression measured using microarray and RT-qPCR	—

Measure

Time frame

Original primary outcome: 1. Development of sepsis, measured using the “sepsis 2” criteria which is a Systemic Inflammatory Response Syndrome (SIRS) characterised by 2 of the following (measured daily for 7 days after surgery): 1.1. Temperature >38 or 20/min or PCO2 90/min after fluid resuscitation measured by clinical observation 1.4. White cell count >10 or 10% immature forms measured by blood test A clinical adjudication panel sifted blinded patient data (including all relevant patient observations and clinical data) to determine which patients adhered to this criteria and which did not. The definition of the study’s primary outcome (SEPSIS) was later changed to be defined as organ dysfunction (characterised by an increase in daily Sequential Organ Failure Assessment (SOFA) score of 2 or more from one day to the next) caused by an infectious agent. Sufficient clinical data was collected during the study to enable identification of patients who achieved the new “sepsis 3” criteria. The parameters for SOFA score include (measured using standard clinical biochemistry and haematology assays, daily for up to 7 days after surgery): 1.1. Respiratory system function (PO2/FiO2 mmHg/kPa >400 to 150 to 12.0 mg/dl) 1.4. Cardiovascular system function (MAP or medication to maintain MAP) 1.5. Central nervous system function (Glasgow Coma Score) 1.6. Renal system function (Creatinine levels 5.0 mg/dl) 2. Biomarkers in whole blood samples (collected daily for 7 days) of patients who go on to develop sepsis, assessed using gene expression measured using microarray and RT-qPCR

—

Secondary

Measure	Time frame
1. The time point at which sepsis occurred judged by a clinical advisory panel using the information collected for the primary outcome measures 2. Identification of alternative biomarkers such as proteins and metabolomic by-products was enabled through the collection of patient sera at the same time points as whole blood. Secondary analysis of protein expression by immunoassay in serial serum samples will enable identification of biomarker signatures that do not rely on RT-qPCR	—

Measure

Time frame

1. The time point at which sepsis occurred judged by a clinical advisory panel using the information collected for the primary outcome measures 2. Identification of alternative biomarkers such as proteins and metabolomic by-products was enabled through the collection of patient sera at the same time points as whole blood. Secondary analysis of protein expression by immunoassay in serial serum samples will enable identification of biomarker signatures that do not rely on RT-qPCR

—

Countries

England, Germany, United Kingdom

Contacts

Public ContactRoman Lukaszewski

ralukaszewski@dstl.gov.uk+44 (0)1980 957424

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026