PORTAL: Pilot study on the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection: a double-blind randomized placebo-controlled trial

Table 2 Flow chart, PORTAL study

Phase	Pre-OP day¹	OP day¹	Post-OP day 1–7¹
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
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.

ISSN: 1471-2482