---
title: Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)
nct_id: NCT02872155
overall_status: COMPLETED
phase: PHASE3
sponsor: David Garcia Cinca
study_type: INTERVENTIONAL
primary_condition: Renal Insufficiency
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02872155.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02872155"
ct_last_update_post_date: 2021-02-02
last_seen_at: "2026-05-12T07:32:39.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)

**Official Title:** Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients

**NCT ID:** [NCT02872155](https://clinicaltrials.gov/study/NCT02872155)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 264
- **Lead Sponsor:** David Garcia Cinca
- **Collaborators:** Fundacion Clinic per a la Recerca Biomédica
- **Conditions:** Renal Insufficiency
- **Start Date:** 2017-07-04
- **Completion Date:** 2019-07-15
- **CT.gov Last Update:** 2021-02-02

## Brief Summary

This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients of both sexes over 18 years
* Candidates for a study with computed tomography and intravenous contrast
* A glomerular filtration rate between 30 and 45 mL / min including both determinations
* They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its

Exclusion Criteria:

* refuse to participate in the study
* pregnancy or lactation
* Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure \<100), being treated with nephrotoxic medications.
* Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
```

## Arms

- **Oral hydratation** (EXPERIMENTAL)
- **Endovenous hydratation** (ACTIVE_COMPARATOR)

## Interventions

- **Oral hydratation** (OTHER) — 500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
- **Bicarbonate endovenous hydratation** (DRUG) — Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.
- **Saline endovenous hydratation** (DRUG) — If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.

## Primary Outcomes

- **Proportion of contrast induced nephropathy** _(time frame: 48-72 hours after the completion of the computed tomography)_ — Contrast induced nephropathy defined as a creatinine increase\> 0.5 mg

/ dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography

## Secondary Outcomes

- **Need for hemodialysis** _(time frame: 15 days)_
- **Reversibility of contrast induced nephropathy** _(time frame: 15 days)_
- **Proportion of adverse events** _(time frame: 15 days)_

## Locations (1)

- Hospital Clínic i Provincial de Barcelona, Barcelona, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital clínic i provincial de barcelona|barcelona||spain` — added _(2026-05-12)_

---

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