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van CCT (UK)

Influence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery.

- candidate number12189
- NTR NumberNTR3380
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-apr-2012
- Secondary IDsNL32416 METC UMCU
- Public TitleInfluence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery.
- Scientific TitleInfluence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery.
- hypothesisEGDT reduces the incidence of major complications in high-risk, abdominal surgery.
- Healt Condition(s) or Problem(s) studiedCardiac output, Abdominal surgery, High-risk surgery, Early goal-directed therapy (EGDT), Arterial waveform analysis
- Inclusion criteria1. Patients undergoing the following elective operations, irrespective of their ASA status:
A. Esophagectomy;
B. Pancreaticoduodenectomy;
C. Open abdominal aorta aneurysm (AAA) repair;
D. Major abdominal resections for soft tissue malignancy, in which post-operative observation in the ICU or PACU is indicated.
2. Patients undergoing the following elective operations, with ASA physical status III or IV:
A. Gastrectomy;
B. Colorectal resections for carcinoma;
C. Other extended upper or lower abdominal surgery for which post-operative observation in the ICU of PACU is indicated.
- Exclusion criteria1. Patients in which cardiac output measurement is indicated;
2. Age < 18 years;
3. Cardiac arrhythmias (atrial fibrillation or flutter, ventricular tachycardia);
4. Emergency surgery;
5. Contraindication for passive leg raising in the entire postoperative period.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-apr-2012
- planned closingdate1-okt-2014
- Target number of participants542
- InterventionsIn patients allocated to EGDT, cardiac output (CO) is continuously measured using arterial waveform analysis until discharge from the ICU or PACU, with a maximum of 24 hours. If CO decreases below a preset, age-dependent, threshold value, a therapy algorithm starts in order to increase CO above the threshold value. In this algorithm, stroke volume variation measurement and passive leg raising are used to guide the choice for fluids or vasoactive substances to increase CO.

Standard care group:
Patients assigned to standard care will be treated according to local routine, with the following conditions:
1. After induction of anesthesia and tracheal intubation, patients will be mechanically ventilated (volume control) with a fixed tidal volume of 8 ml?kg-1 (ideal body weight, IBW) throughout the procedure, adjusting respiratory rate to maintain normocapnia;
2. An arterial line, central venous line and urine catheter are placed;
3. Hypotension after induction is treated with cristalloids or colloids first, with a maximum of 500 ml. Ongoing hypotension is treated with continuous infusion of norepinephrine. Sudden, short-lasting hypotension is treated with phenylephrine, ephedrine, or cafedrine/theodrenaline, depending on local routine;
4. Transfusions will be applied according to the 4-5-6 rule.
Therapy is aimed at maintaining:
1. SpO2 >/= 95%;
2. MAP >/= 60 mmHg or 25% below baseline in case of preexisting hypertension;
3. Heart rate < 100?min-1 or 25% above baseline.
- Primary outcomeThe primary outcome is a combined endpoint of the number of major complications within the first 30 days after surgery:
1. Mortality (any cause);
2. Cardiac arrest;
3. Myocardial infarction;
4. Pulmonary edema;
5. Stroke;
6. Prolonged mechanical ventilation (>24 hrs);
7. Pulmonary embolism;
8. Pneumonia;
9. Respiratory failure (requiring mechanical ventilation);
10. Acute kidney injury;
11. Anastomotic leak;
12. Re-operation;
13. Wound infection;
14. Sepsis.
These major complications are associated with an increased 30-day and long-term mortality.
- Secondary outcome1. The number of the following minor complications in the first 30 days:
A. Arrhythmia;
B. Deep venous thrombosis;
C. Urinary tract infection;
D. Prolonged ileus;
E. Herniation or other prolonged wound healing.
2. Length of hospital stay;
3. Length of stay in the ICU/PACU;
4. Length of post-operative mechanical ventilation;
5. Continuation of care at intermediate care units;
6. Number of ICU, PACU or intermediate care readmissions in the first 30 days;
7. Discharge destination;
8. Total amount of fluid administrated in the first 24 hours;
9. Amount of vasoactive support in the first 24 hours;
10. Mean urine output in the first 24 hours;
11. Hemodynamic parameters (CO, MAP) in the first 24 hours;
12. Laboratory investigations (serum lactate, ScvO2, ABG) in the first 24 hours;
13. Quality of life (1, 3, 6 and 12 months);
14. Cost-effectiveness (1, 3, 6 and 12 months);
15. Long-term outcome (morbidity and mortality after 3, 6 and 12 months).
- TimepointsThe time points for the outcome measures are indicated above.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht, Division of Vital Functions
- PublicationsN/A
- Brief summaryThe majority of complications after surgery occurs in a minority of patients. EGDT has shown to improve outcome in this patient group, which is high-risk either because of the type of surgery or due to the presence of coexisting disease. However, safety concerns and practical issues associated with advanced hemodyamic monitoring limit the introduction of EGDT in routine practice. Arterial waveform analysis (AWA) provides easy, less invasive, continuous cardiac output measurement, and could therefore guide EGDT. A number of small single-center studies investigating AWA-based EGDT in high-risk surgery showed promising results. However, a multi-center trial in a large patient sample has not been performed yet. In the presented study, we aim to determine whether EGDT, aimed at optimizing CO measured by AWA, improves outcome in high-risk, abdominal surgery. The study design is a multi-center, randomized controlled, clinical study. The study population concerns 542 patients undergoing elective, extended abdominal surgery with an increased risk of postoperative mortality and morbidity.
- Main changes (audit trail)
- RECORD3-apr-2012 - 19-apr-2012

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