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Early goal directed therapy following major surgery reduces complications and duration of hospital stay: a randomised, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38797445
Enrollment
300
Registered
2005-09-28
Start date
2002-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Major general surgery Surgery

Interventions

Goal directed therapy protocol to achieve oxygen delivery index of 600 ml/min/m^2 compared to protocol designed to reflect standard care.

Sponsors

St Georges Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older presenting for major surgery expected to last more than one and a half hours were eligible for inclusion if one or more of the following criteria were satisfied before surgery: 1. Severe cardiac or respiratory illness resulting in severe functional limitation 2. Extensive surgery planned for carcinoma involving bowel anastamosis 3. Acute massive blood loss (greater than 2.5 l) 4. Aged over 70 years with moderate functional limitation of one or more organ systems 5. Septicaemia (positive blood cultures or septic focus) 6. Respiratory failure (partial pressure of oxygen in arterial blood [PaO2] less than 8 kPa on Fraction of inspired Oxygen [FiO2] greater than 0.4, i.e., PaO2 : FiO2 ratio less than 20 kPa or ventilation greater than 48 hours) 7. Acute abdominal catastrophe (e.g., pancreatitis, perforated viscous, gastro-intestinal bleed) 8. Acute renal failure (urea greater than or equal to 20 mmol/l, creatinine greater than 60 µmol/l) 9. Surgery for abdominal aortic aneurysm

Exclusion criteria

Exclusion criteria: 1. Refusal of consent 2. Pregnancy 3. Acute myocardial ischaemia prior to enrolment 4. Patients receiving palliative treatment only 5. Disseminated malignancy 6. Patients unlikely to survive more than 6 hours 7. Patients requiring intervention outside intensive care unit (ICU) within the first 6 hours following surgery 8. Patients on lithium therapy 9. Weight less than 40 kg

Design outcomes

Secondary

MeasureTime frame
Mortality and duration of hospital stay.

Primary

MeasureTime frame
Incidence of post-operative complications.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026