Fibrinogen and albumin synthesis rates in major upper abdominal surgery

• Register: ANZCTR
• Last refreshed on: 21 February 2022
• Main ID: ACTRN12617000749303
• Date of registration: 22/05/2017
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: Fibrinogen and albumin synthesis rates in major upper abdominal surgery
• Scientific title: The temporal pattern of fibrinogen and albumin synthesis rates perioperatively in major liver surgery
• Date of first enrolment: 18/09/2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000749303.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial;
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Dr Gabriel Dumitrescu

• Name: Dr Gabriel Dumitrescu

Key inclusion & exclusion criteria

Inclusion criteria: Patients with indications and admited for elective major hepatic surgery or distal pancreatic resections
Exclusion criteria: 1. No consent
2. A surgical procedure that deviates from the standard hemihepatecomy, extended hemihepatectomy, or the standard Whipple´s procedure.
3. Any condition that the investigator find to be in potential conflict with the 3 standard procedures intended to be studied.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Liver disease;
Liver disease

Surgery - Other surgery

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention(s)

Brief name: Flooding dose technique with stable isotope (D5-phenylalanine) for measuring de novo synthesis of fibrinogen and albumin.

We will study patients undergoing liver resections of variable size , i.e. hemihepatectomy and extended hemihepatectomy (n=9).
Incorporation of D5-phenylalanine into fibrinogen and albumin will analysed by gas chromatography – mass spectrometry.

Patients will be investigated 3 times in the postabsorptive state (not less than 6 h after a warm meal, and not less than 4 h after coffee or tea, tap water is allowed without restriction). Postoperatively iv crystalloid solutions may be administered. If 5% dextrose is given, it should be paused not less that 2h before measurement. The measurements will be preoperatively, not less than 2 days but not more than 5 days before the measurement on postoperative day 1. A 3rd measurement will then be performed on postoperative day 3-5.
All procedures in conjunction with anesthesia, surgery and postoperative care will be in accord with the local routines at Karolinska University Hospital Huddinge, and at the discretion of the attending anesthesiologist and/or surgeon. At the preoperative measurement two venous accesses will be inserted. At the postoperative measurements existing vascular accesses will be utilized. The routine blood sampling for preoperative and postoperative surveillance will be adjusted time-wise to occur simultaneously with the measurements.
Measurement procedures will be identical except for the isotopic enrichment of D5-phenylalanine. D5-phenylalanine will be administered intravenous during 10 minutes of a 2% phenylalanine solution (45mg/kg, 5, 10 and 30 MPE [mols percent excess]) on the 3 measurement occasions. Thereafter venous blood samples will be obtained

Primary Outcome(s)

Change in fibrinogen absolute synthesis rate assessed by isotopic techniques linked with detection by mass spectrometry.
[Baseline(preoperatively), postoperative day 1 , postoperative day 3-5]

Secondary Outcome(s)

Change in albumin absolute synthesis rate assessed by isotopic techniques linked with detection by mass spectrometry.[Baseline(preoperatively), postoperative day 1, postoperative day 3-5 ]

To explore if the absolute and fractional synthesis rates of fibrinogen and albumin, assessed by isotopic techniques linked with detection by mass spectrometry., correlate following hemihepatectomy and extended hemihepatectomy[Baseline(preoperatively), postoperative day 1, postoperative day 3-5 ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Swedish Medical Research Council

Secondary Sponsor(s)

Karolinska University Hospital

Ethics review

Status: Approved
Approval date: 20/02/2017
Contact:

Regional Ethical Review Board in Stockholm

Results

• Results available: Yes
• Date Posted: 05/03/2020
• Date Completed: 03/06/2019