Goal-directed therapy: to determine a systematic approach in reducing complications after a cardiac surgery

Randomised controlled trial of post-operative goal-directed haemodynamic therapy following a cardiac surgery and the effects on acute kidney injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72151906

Enrollment

4000

Registered

2013-11-25

Start date

2016-01-01

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

Complications following cardiac surgery, specifically acute kidney injury and renal function Circulatory System Other functional disturbances following cardiac surgery

Interventions

Current interventions as of 14/10/2014: Patients in the control group will have routine post-operative care with the standard haemodynamic targets of: 1. Systolic blood pressure within 20% of baselin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Coronary artery bypass grafts (CABG), aortic valve replacement (AVR) or combined CABG and AVR 2. Informed consent 3. Admission to intensive care from theatre 4. Patients over 18 years of age

Exclusion criteria

Exclusion criteria: 1. Myocardial infarction (MI) less than 48 hours prior to surgery 2. Infective endocarditis 3. Chronic Kidney Disease Stage 5 (end stage renal failure) 4. Cardiogenic shock requiring intra-aortic balloon pump 5. Pulmonary hypertension WHO-FC III/IV 6. Known right ventricular failure 7. Diagnosis of congenital heart disease Added 14/10/2014: 8. Renal replacement therapy prior to surgery within 30 days

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 14/10/2014: The primary outcome variable for this study is Acute Kidney Injury (AKI) that requires renal replacement therapy within 7 days following cardiac surgery. Death before day 7 is a competing risk and will be treated in the analysis accordingly. One approach would consist of a multinomial logit model, which deals with unordered multichotomous dependent variables, i.e. both death and AKI. Previous primary outcome measures: The primary outcome variable for this study is Acute Kidney Injury (AKI) stage 1 or above as defined by the AKIN criteria. Day 3 creatinine, compared to the most recent pre-operative value, will be used. Day of surgery is considered day 0. Death before day 3 is a competing risk and will be treated in the analysis accordingly. One approach would consist of a multinomial logit model, which deals with unordered multichotomous dependent variables, i.e. both death and AKI.	—

Measure

Time frame

Current primary outcome measures as of 14/10/2014: The primary outcome variable for this study is Acute Kidney Injury (AKI) that requires renal replacement therapy within 7 days following cardiac surgery. Death before day 7 is a competing risk and will be treated in the analysis accordingly. One approach would consist of a multinomial logit model, which deals with unordered multichotomous dependent variables, i.e. both death and AKI. Previous primary outcome measures: The primary outcome variable for this study is Acute Kidney Injury (AKI) stage 1 or above as defined by the AKIN criteria. Day 3 creatinine, compared to the most recent pre-operative value, will be used. Day of surgery is considered day 0. Death before day 3 is a competing risk and will be treated in the analysis accordingly. One approach would consist of a multinomial logit model, which deals with unordered multichotomous dependent variables, i.e. both death and AKI.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 14/10/2014: 1. AKIN and RIFLE criteria for AKI 2. The incidence of renal replacement therapy within the same hospital admission. This is defined as haemofiltration, haemodialfiltration within intensive care and haemodialysis on the renal dialysis unit 3. Re-admission to intensive care within 30 days of surgery 4. Time to readiness for discharge from intensive care as per unit guidelines 5. Time to medically fit for discharge from hospital as decided by the clinical team. Transfer to another hospital will be considered additional stay in acute care unless transferred for social reasons only 6. Time to actual discharge from hospital 7. Respiratory, infectious, renal, gastrointestinal, cardiovascular, haematological, biochemical and wound infections as predefined in the protocol 8. Morbidity and organ failure scores as defined by Sequential Organ Failure Assessment (SOFA) 9. Morbidity scores for ward patients using cardiac postoperative morbidity score (C-POMS) at day 1, day 3, day 5 and day 8 10. In-hospital mortality 11. Mortality at day 30, 6 months and 1 year 12. Health survey at 30 days and 1 year Previous secondary outcome measures: 1. RIFLE criteria: the incidence of renal replacement therapy within the same hospital admission. This is defined as haemofiltration, haemodialfiltration within intensive care and haemodialysis on the renal dialysis unit. 2. Re-admission to intensive care within 30 days of surgery 3. Time to readiness for discharge from intensive care as per unit guidelines 4. Time to medically fit for discharge from hospital as decided by the clinical team. Transfer to another hospital will be considered additional stay in acute care unless transferred for social reasons only. 5. Time to actual discharge from hospital 6. Respiratory, infectious, renal, gastrointestinal, cardiovascular, haematological, biochemical and wound infections 7. Morbidity and organ failure scores as defined by Sequential Organ	—

Measure

Time frame

Current secondary outcome measures as of 14/10/2014: 1. AKIN and RIFLE criteria for AKI 2. The incidence of renal replacement therapy within the same hospital admission. This is defined as haemofiltration, haemodialfiltration within intensive care and haemodialysis on the renal dialysis unit 3. Re-admission to intensive care within 30 days of surgery 4. Time to readiness for discharge from intensive care as per unit guidelines 5. Time to medically fit for discharge from hospital as decided by the clinical team. Transfer to another hospital will be considered additional stay in acute care unless transferred for social reasons only 6. Time to actual discharge from hospital 7. Respiratory, infectious, renal, gastrointestinal, cardiovascular, haematological, biochemical and wound infections as predefined in the protocol 8. Morbidity and organ failure scores as defined by Sequential Organ Failure Assessment (SOFA) 9. Morbidity scores for ward patients using cardiac postoperative morbidity score (C-POMS) at day 1, day 3, day 5 and day 8 10. In-hospital mortality 11. Mortality at day 30, 6 months and 1 year 12. Health survey at 30 days and 1 year Previous secondary outcome measures: 1. RIFLE criteria: the incidence of renal replacement therapy within the same hospital admission. This is defined as haemofiltration, haemodialfiltration within intensive care and haemodialysis on the renal dialysis unit. 2. Re-admission to intensive care within 30 days of surgery 3. Time to readiness for discharge from intensive care as per unit guidelines 4. Time to medically fit for discharge from hospital as decided by the clinical team. Transfer to another hospital will be considered additional stay in acute care unless transferred for social reasons only. 5. Time to actual discharge from hospital 6. Respiratory, infectious, renal, gastrointestinal, cardiovascular, haematological, biochemical and wound infections 7. Morbidity and organ failure scores as defined by Sequential Organ

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Countries

United Kingdom

Outcome results

None listed

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