The Impact of glutamine suppletion on outcome in patients undergoing high-risk cardiothoracic surgery.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004217-18-NL

Enrollment

Registered

2006-08-03

Start date

2007-02-06

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Infectious complications after high-risk cardiothoracic surgery. MedDRA version: 8.1 Level: LLT Classification code 10051284 Term: Parenteral nutrition

Interventions

Trade Name: Dipeptiven Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with a left ventricular ejection fraction of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Less than 18 years old • Emergency operations • Renal impairment as defined by a calculated creatinine clearance of < 25 mL/min using the Cockroft & Gault formula: Crc (men) (ml/min)= [140-age (years)*Total body weight (kg)]/plasma creatinin (µmol/l)*1,23 Crc (women) (ml/min)= [140-age (years)*Total body weight (kg)]/plasma creatinin (µmol/l)*1,05 • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the study is to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on infectious morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. ;Secondary Objective: Secondary objectives of the study are to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on cardiac, cerebral, pulmonary and gastro-intestinal morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. Furthermore, the effect on length of stay in the ICU-, hospital- and on in-hospital mortality will be studied. ;Primary end point(s): Infectious complications: - Systemic Inflammatory Response Syndrome (Two or more of the following: • Temperature >38 ºC or 90 bpm • Respiratory rate > 20 breaths/min • White blood cell count > 12.000/mm3, 120 mg/dL) in absence of diabetes • Inflammatory variables: plasma C-reactive protein > 2 SD above the normal value. • Mixed venous oxygen saturation (SVO2) > 70 % • Cardiac index > 3.5 L min-1 M-23 Severe sepsis Sepsis associated with organ dysfunction (see appendix F), hypoperfusion abnormalities, or hypotension. Hypoperfusion abnormalities include, but are not limited to: • Arterial hypoxemia (PaO2/fraction of inspired oxigen [FiO2] ratio of 2.0 mg/dL • Coagulation abnormalities (INR > 1.5 APTT > 60 sec) • Platelet count 2mg/dL or 35 mmol/L) • Tissue-perfusion variable: hyperlactatemia (> 2 mmol/L) • Hemodynamic variables: arterial hypotension (systolic blood pressure 40 mmHg))	—

Measure

Time frame

Main Objective: Main objective of the study is to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on infectious morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. ;Secondary Objective: Secondary objectives of the study are to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on cardiac, cerebral, pulmonary and gastro-intestinal morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. Furthermore, the effect on length of stay in the ICU-, hospital- and on in-hospital mortality will be studied. ;Primary end point(s): Infectious complications: - Systemic Inflammatory Response Syndrome (Two or more of the following: • Temperature >38 ºC or 90 bpm • Respiratory rate > 20 breaths/min • White blood cell count > 12.000/mm3, 120 mg/dL) in absence of diabetes • Inflammatory variables: plasma C-reactive protein > 2 SD above the normal value. • Mixed venous oxygen saturation (SVO2) > 70 % • Cardiac index > 3.5 L min-1 M-23 Severe sepsis Sepsis associated with organ dysfunction (see appendix F), hypoperfusion abnormalities, or hypotension. Hypoperfusion abnormalities include, but are not limited to: • Arterial hypoxemia (PaO2/fraction of inspired oxigen [FiO2] ratio of 2.0 mg/dL • Coagulation abnormalities (INR > 1.5 APTT > 60 sec) • Platelet count 2mg/dL or 35 mmol/L) • Tissue-perfusion variable: hyperlactatemia (> 2 mmol/L) • Hemodynamic variables: arterial hypotension (systolic blood pressure 40 mmHg))

—

Countries

Netherlands

Outcome results

None listed

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