FindTrial
Sign In

Solutions comparison as kidney function protectors in patients undergoing a partial laparoscopic nephrectomy

Randomized clinical trial to compare the effect of mannitol and hydroelectrolytic solutions as kidney function protector, in partial laparoscopic nephrectomies (MANCOL Study) - MANCOL

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003398-24-ES
Enrollment
Unknown
Registered
2012-09-07
Start date
2012-10-29
Completion date
Unknown
Last updated
2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

partial laparoscopic nephrectomy MedDRA version: 15.0 Level: LLT Classification code 10047691 Term: Volume depletion System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 15.0 Level: LLT Classification code 10034072 Term: Partial nephrectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: osmofundina Product Name: MANNITOL Product Code: 43560 Pharmaceutical Form: Solution for infusion INN or Proposed INN: mannitol Other descriptive name: MANNITOL Concentration unit: mg/kg m

Sponsors

FUNDACIÓ PUIGVERT
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients older than 18; Patients undergoing a partial laparoscopic nephrectomy; Preoperative ASA ? III` Preoperative and intraoperative anaesthesia according to clinical practice Surgical procedure without complications Previous informed consent of patients 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: Pregnancy or Breastfeeding Obesity or overweight, BMI >= 20% regarding ideal GF < 60ml/min Severe coronary desease (NYHA class. III and IV) Allergy to drugs used during anaesthesia

Design outcomes

Primary

MeasureTime frame
Main Objective: Assess wether there are differences in the glomerular filtration rate 6 months after laparoscopic partial nephrectomy according administered fluid therapy;Secondary Objective: study wether there are differences among 3 arms in: diuresis during the first postoperative 24 hours; central venous pressure during the first postoperative 24 hours; intraocular pressure during surgical procedure; Blood pressure changes during surgical procedure and in the postoperative period; Postoperative nausea and vomiting incidence; bleeding during surgical procedure and in the postoperative period; possible complications.;Primary end point(s): Glomerular filtration rate at 6 months;Timepoint(s) of evaluation of this end point: 6 months—

Secondary

MeasureTime frame
Secondary end point(s): diuresis during first 24 hours central venous pressure during first 24 hours intraocular pressure blood pressure changes nausea and vomiting Bleeding Complications;Timepoint(s) of evaluation of this end point: During the procedure, postoperative period and at 6 months—

Countries

Spain

Contacts

Public ContactAgència de Gestió del Coneixement

FUNDACIÓ PUIGVERT

agescon@fundacio-puigvert.es34934169731

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026