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The effect of intraoperative replacement solutions with hydroxyethylstarch and lactated ringer on renal function in patients undergoing abdominal uterine removal surgery

Effects of intraoperative volume replacement with hydroxyethylstarch and lactated ringer on renal function of patients undergoing open hysterectomy: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7j75q5
Enrollment
Unknown
Registered
2018-07-09
Start date
2015-11-03
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Healthy patients

Interventions

Patients, who agree to participate in the study, will be randomized into 2 intervention groups (6% hydroxyethyl starch solution (HES) 130 / 0.4) and control (ringer lactate solution). There will be 30
Drug
Procedure/surgery
E04.249
E04.950.300.399
E01.370.390.400
D23.101
C23.550.767
E04.614

Sponsors

Faculdade de Medicina de Botucatu - UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu - UNESP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; female; preserved renal function; open abdominal hysterectomy; general anesthesia;

Exclusion criteria

Exclusion criteria: Patient refusal; altered renal function; use of diuretics; obesity; decompensated hypertension; decompensated diabetes mellitus;

Design outcomes

Primary

MeasureTime frame
To compare the times of anesthesia recovery and hospitalization, by concomitant follow-up of patients in the perioperative period;;To evaluate and compare the biomarkers dosage of renal function, measured by laboratory analysis in the preoperative period, on the 1st postoperative day and 40 days after surgery;;To compare intra and postoperative urinary output through bladder catheterization;;Relate changes of renal function biomarkers with intraoperative hemodynamic monitoring, through laboratory analysis and vital signs data during surgery;—

Secondary

MeasureTime frame
To compare the total infused volume of colloid and crystalloid solutions in the intraoperative period;;To compare the amount of blood loss, by quantification in vacuum cleaners and weight of compresses, and the need for intra and postoperative blood transfusions;;To compare the incidence of other postoperative complications;To compare the morbidity and mortality rates at 7 and 40 days after surgery.;Postoperative pain score based on Verbal Analog Scale;—

Countries

Brazil

Contacts

Public ContactLais ;Murillo Navarro e Lima;Santos

Faculdade de Medicina de Botucatu - UNESP;Faculdade de Medicina de Botucatu - UNESP

laishnavarro@fmb.unesp.br;murillogsantos@gmail.com+55-14-3880-1414;+55-14-3880-1414

Outcome results

None listed

Source: REBEC (via WHO ICTRP)