This study aims to investigate a new crystalloid fluid therapy regime for the perioperative setting providing stable fluid and acid-base homeostasis in the patient.
Conditions
Interventions
Trade Name: Jonosteril®
Pharmaceutical Form: Infusion
Trade Name: Sodiumglycerophosphate
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: SODIUM GLYCEROPHOSPHATE
CAS Nu
Sponsors
University Hospital Munich, Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • only female patients who have given their informed consent • ASA I-III classified female patients, who are scheduled for an extended abdominal surgical procedure under general anesthesia with routinely planned placement of a central venous and arterial catheter • age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: •participation in another clinical trial •patients who are not personally able to giver their informed consent •patients at a childbearing age without using contraceptives • acute or chronic renal failiure (glomerular filtration rate <60ml/min) • patients suffering from acid-base-dysregulation (i.e. severe acidosis, sepsis, SIRS) • pregnancy or lactation period (pregnancy testing will be executed on the ward at least one day prior to the surgical procedure) • edema, hypertonic dehydratation, hyperhidratation • hyperphosphatemia, hypernatremia,hypocalcemia • known hypersensitivity against IMPs and/or other components • known history or active abuse of alcohol and/or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: An aedequate perioperative fluid therapy should be capable of replacing fluid (such as urinary output and insensible perspiration) and limited blood losses without disturbing fluid and acid-base homeostasis within the human body. With the use of state of the art crystalloids preparations we often observe the onset of a hyperchloremic acidosis with all its negative consequences like the reduction of renal function, among others. Our hypothesis is based on the Stewart model of acid-base balance where albumin and phosphate, referred to as weak acids (A-), are capable of regulating the pH. Adding sodium glycerophosphate to an established crystalloid preparation, our main objective is to stabilize the level of A- in the patient in order to maintain constant acid-base conditions. ;Secondary Objective: Secondary objectives of the trial are : the effects of the crystalloid preparation on -The onset and severity of postoperative nausea and vomiting (PONV) -Other Stewart acid-base parameters -Electrolyte levels and their excretion in the urine -Hemodynamics -Amounts of catecholamines and vasopressors used and the safety of the infusion regime ;Primary end point(s): Calculation of the week acids concentration (A-) according to the Stewart approach of acid-base balance: A- = albumin x (0.123 x pH – 0.631) + phosphate x (0.309 x pH - 0.469) ;Timepoint(s) of evaluation of this end point: Calculation takes place after measurement of pH, serum phosphate and albumin during distinct timepoints (every 30 minutes until 120 minutes after the induction of anesthesia) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) analysis of serum phosphate levels 2) analysis of acid-base parameters: pH, paCO2, HCO3-, BE, anion gap 3) analysis of Strong Ion Difference (SID), Effective Strong Ion Difference, Strong Ion Gap, albumin, lactate 4) serum and urine analysis of electrolytes 5) documentation of blood pressure, heart frequency, demand of catecholamines and vasopressors, variation in stroke volume and cardiac output 6)analysis of creatinine and urea as well as calculation of glomeraular filtration rate 7) analysis of glykokalix components (hyaluronic acid, syndecan-1) 8) evaluation and documentation of postoperative nausea and vomiting ;Timepoint(s) of evaluation of this end point: 1)-5) starting after induction of anesthesia (T1) on the day of the surgical procedure until 120min after T1 6) one day prior to the surgical procedure as well as on day 3 7) T1 -T5 8) at the end of the surgical procedure as well as on day 1 and 3 after surgery | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Markus Rehm
University Hospital Munich
Outcome results
None listed