|
Flow chart, PORTAL study |
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| Phase |
Pre-OP day1 |
OP day1 |
Post-OP day 1–71 |
|
|
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| Study-day |
-1 |
0 |
1–7 |
| Medical history |
X |
||
| Physical examination |
X |
||
| Inclusion/exclusion criteria |
X |
||
| Karnowsky index |
X |
||
| Patient information |
X |
||
| Patient informed consent |
X |
||
| Concomitant medication |
X |
X |
|
| Documentation of surgery (OPS code) |
X |
||
| Clinical outcome |
|||
| Bilioma, pleural effusion, pneumonia, wound infection, peritonitis, UTI, sepsis |
X |
||
| Safety and Tolerance |
|||
| Adverse events (AE) |
X |
X |
|
| Liver |
|||
| Integrity: AST, AP, GGT, ALT, LDH, GSH |
X |
X |
X |
| Synthesis: CE, Chol, TP, PT, PTT albumin, CRP |
X |
X |
X |
| Elimination: Bilirubin |
X |
X |
X |
| Kidney |
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| Crea (blood), Na, K, Ca, Cl |
X |
X |
X |
| Urea-N. |
X |
X |
X |
| Crea (urine) for Crea-Clearance |
X |
X |
|
| Substrates, metabolites, cytokines |
|||
| Glucose, TG, lactate, IL-6, melatonin2 |
X |
X |
X |
| Hematology |
|||
| Hb, Hc, Thr, Leuko, Ery |
X |
X |
X |
|
1 sampling at the same time each day, e.g. 8:00, 2 sampling before, 2 h and 4 h after melatonin application Pre-OP, pre-operative period; OP, operation/day of operation; Post-OP, post-operative period; OPS, "Operations- und Prozedurenschlüssel" [codes for operations and procedures]; UTI, urinary tract infection; AST, aspartate amino-transferase; AP, alkaline phosphatase; GGT, γ-glutamyl transferase; ALT, alanine aminotransferase; LDH, lactate dehydrogenase; GSH, glutathione; CE, choline esterase; Chol, Cholesterol, TP, total protein; PT, prothrombin time; PTT, partial thromboplastin time, CRP, c-reactive protein, Crea, creatinine; Na, natrium; K, kalium; Ca, calcium; Cl, chloride; Urea-N, urea-nitrogen; TG, triglyceride; IL, interlukin; Hb, hemoglobin, Hc, hematocrit, Thr, thrombocyte, Leuko, leukocyte; Ery, erythrocyte. | |||
Schemmer et al. BMC Surgery 2008 8:2 doi:10.1186/1471-2482-8-2 |
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