Clinical trial NCT02808325: Study on the Efficacy and Safety of Gelaspan
Official title: Prospective Controlled Randomized Double-blind Multicentre Study in Parallel Groups on the Efficacy and Safety of Gelaspan in Combination With Sterofundin ISO in Comparison With Gelofusine in Combination With Sodium Chloride Braun in Patients Scheduled for Abdominal or Pelvic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypovolemia
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.


Eligibility criteria: Inclusion:

* Male or female patients ≥ 18 years of age and ≤ 80 years of age.
* Patients scheduled to undergo open elective abdominal or pelvic surgery.
* Anticipated intraoperative volume requirement for gelatine solution is at least 15 mL/kg body weight
* Negative pregnancy test (urine dipsticks) in women of child bearing potential.
* 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 regulatory authorities of the Russian Federation and Local Ethics Committee (LEC) 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)
  * Hypervolemia;
  * Severe heart failure;
  * Moderate lung edema;
  * Hyperhydration;
  * Severe blood coagulation disorders (aPTT \>2.5 x ULN or fibrinogen \< 0.5 x LLN or INR \>2.5 x ULN);
  * Hypernatremia (serum Na+ \> 150 mmol/L);
  * Hyperchloremia (serum Cl- \> 110 mmol/L);
  * Hypercalcemia (serum ionized Ca++ \> 1.5 mmol/L);
  * Metabolic alkalosis;
  * Severe generalized edema;
  * Intracranial haemorrhage;
  * Hyperkalemia (serum K+ \> 5.5 mmol/L).
* Pregnancy and/or nursing.
* Hypertension with the Systolic Blood Pressure \> 180 mm Hg and Diastolic Blood Pressure \> 110 mm Hg identified at screening.
* Patients who in the investigator's opinion couldn't take part in the study.
* Simultaneous participation in another clinical trial.
* Emergencies.

Primary outcomes:
measure: Base Excess
timeFrame: Change in base excess from baseline to end of surgery
Secondary outcomes:
measure: Base Excess
timeFrame: Change in base excess from baseline to 12 hours after end of surgery
measure: Adverse events
timeFrame: until 12 hours after end of surgery
measure: Hemodynamics
timeFrame: until 12 hours after end of surgery
measure: Renal Function
timeFrame: until 12 hours after end of surgery
measure: Arterial blood gas analysis
timeFrame: until 12 hours after end of surgery
measure: Coagulation status
timeFrame: until 12 hours after end of surgery
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Road Clinical Hospital of JSC "Russian Railways
city: Saint-Petersburg
country: Russian Federation
facility: North-Western Federal Medical Research Center n.a. V.A. Almazov
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
Study officials:
References: