Clinical trial NCT01515397: Comparison of Two Gelatine Solutions
Official title: Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypovolemia
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.


Eligibility criteria: Inclusion:

* Male or female patients \>= 18 years of age and \<= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
* Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
* Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

* Patients of ASA-class \> III
* Known hypersensitivity to gelatine or to any of the constituents of the solution
* Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
* Patients on hemodialysis
* Patients suffering from decompensated renal function (i.e. serum creatinine \> 3.0 mg/dl)
* Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) \> 150 mmol/L) Hyperchloremia (serum(Cl-) \> 110 mmol/L)
* Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
* Lactation period
* Simultaneous participation in another clinical trial
* Emergencies

Primary outcomes:
measure: base excess [mmol/l]
timeFrame: Change from baseline at end of surgery, an expected average of 2 hours surgery
measure: chloride [mmol/l]
timeFrame: Change from baseline at end of surgery, an expected average of 2 hours surgery
Secondary outcomes:
measure: arterial blood gase analyses
timeFrame: until 12 hours after surgery
measure: coagulation status
timeFrame: until 12 hours after surgery
measure: renal function
timeFrame: until 12 hours after surgery
measure: adverse events
timeFrame: until 12 hours after surgery
measure: hemodynamics (systolic and diastolic blood pressure)
timeFrame: until 12 hours after surgery
measure: time on ventilation
timeFrame: until 12 hours after surgery
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Klinik für Anästhesiologie
city: Frankfurt/Main
country: Germany
facility: Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
Study officials:
affiliation: Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
name: Gernot Marx, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.