Clinical trial • Not applicable • Other

Human albumin solution for Perioperative fluid therapy in laparoscopic abdominal surgery

Not applicable trial of Human albumin solution for Perioperative fluid therapy in laparoscopic abdominal surgery.

Overview

Trial Therapeutic Area
Other
Trial Disease
Perioperative fluid therapy in laparoscopic abdominal surgery
Trial Stage
Not applicable
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
15-04-2024
First CTIS Authorization Date
26-04-2024

Trial design

Comparator arms: Albumin (human albumin solution, intravenous; product max daily/total amount listed as 50 g) versus Ringer's solution/electrolytes (intravenous; product max daily/total amount listed as 3 L). Administration is intravenous during planned laparoscopic abdominal surgery; treatment described as fluid infusion.-controlled Not applicable trial across 2 sites in Sweden.

Comparator
Comparator arms: Albumin (human albumin solution, intravenous; product max daily/total amount listed as 50 g) versus Ringer's solution/electrolytes (intravenous; product max daily/total amount listed as 3 L). Administration is intravenous during planned laparoscopic abdominal surgery; treatment described as fluid infusion.
Target Sample Size
60
Trial Duration For Participant
1

Eligibility

Recruits 60 No vulnerable population selected. Written informed consent from the participant is required ("Forskningspersonen har gett sitt skriftliga samtycke till att delta i studien."). Individuals with mental incapacity, reading, vision or language difficulties are excluded ("Mental oförmåga, läs, syn eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien")..

Pregnancy Exclusion
Graviditet, amning eller planerad graviditet.
Vulnerable Population
No vulnerable population selected. Written informed consent from the participant is required ("Forskningspersonen har gett sitt skriftliga samtycke till att delta i studien."). Individuals with mental incapacity, reading, vision or language difficulties are excluded ("Mental oförmåga, läs, syn eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien").

Inclusion criteria

  • {"criterion_text":"- Forskningspersonen har gett sitt skriftliga samtycke till att delta i studien."}
  • {"criterion_text":"- För kvinnliga deltagare i fertil ålder ska adekvat preventivmedel användas, t.ex. P-piller, spiral eller P-stav eller ett negativt graviditetstest. För postmenopausala gäller ingen mens på 12 månader för att frångå kravet på effektiv preventivmedel."}
  • {"criterion_text":"- Deltagare ska tillhöra ASA (American Society of Anesthesiology) klassificering I till III."}
  • {"criterion_text":"- Planerad större laparoskopisk bukkirurgi, som planeras vara i 90 minuter eller mer."}
  • {"criterion_text":"- 18 till 85 års ålder"}

Exclusion criteria

  • {"criterion_text":"- Patienter med känd hjärtsvikt"}
  • {"criterion_text":"- <18 år eller >80 år"}
  • {"criterion_text":"- Känd eller misstänkt allergi mot albumin, överkänslighet mot de aktiva substanserna eller mot något hjälpämne."}
  • {"criterion_text":"- Extracellulär hyperhydrering eller hypervolemi"}
  • {"criterion_text":"- Uttalad njurfunktionsnedsättning."}
  • {"criterion_text":"- Graviditet, amning eller planerad graviditet."}
  • {"criterion_text":"- Mental oförmåga, läs, syn eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien"}
  • {"criterion_text":"- Deltar eller nyligen deltagit eller i en klinisk läkemedelsprövning, de senaste 30 dagarna. Tidigare deltagande i denna studie."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Hemoglobinsänkning i samband med vätskebolus, vilken bearbetas matematiskt i en kinetisk modell.","definition_or_measurement_approach":"Decrease in hemoglobin associated with a fluid bolus, analysed/processed mathematically using a kinetic model."}

Secondary endpoints

  • {"endpoint_text":"- Cirkulationsfysiologiska mätningar. Förändring i P-albumin, P-Kreatinin, Vätskesammansättning och vätskebalans preoperativt och efter ett dygn.","definition_or_measurement_approach":"Circulatory physiological measurements: changes in plasma albumin (P-albumin), plasma creatinine (P-Kreatinin), fluid composition and fluid balance measured preoperatively and 24 hours postoperatively."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
38
Consent Approach
Written informed consent is required from each participant ("Forskningspersonen har gett sitt skriftliga samtycke till att delta i studien."). For females of childbearing potential, effective contraception or a negative pregnancy test is required. No information provided on assent for minors (minors are excluded). No languages or translated documents specified.

Geography

Total Number Of Sites
2
Total Number Of Participants
60

Sweden

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
24
Number Of Sites
2
Number Of Participants
60

Sites

Site Name
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Department Name
Anestesi och intensivvårdskliniken, Norrköping
Contact Person Name
Robert Svensson
Site Name
Region Oestergoetland (Universitetssjukhuset I Linkoping)
Department Name
Anestesi och intensivvårdskliniken, Linköping
Contact Person Name
Hans Bahlmann

Sponsor

Primary sponsor

Full Name
Region Oestergoetland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
ELECTROLYTES
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Product authorisation status code: 2; marketingAuthorisationNumber: -
Maximum Dose
3 l
Investigational Product Name
ALBUMIN
Active Substance
Human albumin solution
Modality
Peptide/protein/enzyme
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Product authorisation status code: 2; marketingAuthorisationNumber: -
Maximum Dose
50 g

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